Sr. Director Quality
Position Summary The Director of Quality - Multi-Site will provide strategic leadership, direction, and oversight of Quality operations across multiple manufacturing and/or development sites. This role ensures that all sites meet regulatory compliance, maintain consistent quality standards, and drive continuous improvement initiatives. The Director will collaborate with cross-functional teams, providing quality leadership to align processes, systems, and culture to company objectives while ensuring compliance with FDA, ISO 13485, and other applicable global regulations. Key Responsibilities Strategic Quality Leadership Develop and implement a strategic quality vision for all sites, ensuring alignment with company goals and regulatory requirements. Standardize and harmonize Quality Management System (QMS) processes, policies, and procedures across multiple sites to ensure consistent application and compliance. Serve as the senior quality leader for all multi-site operations, promoting a culture of quality, accountability, and continuous improvement. Collaborate with executive leadership to define quality-related strategies, objectives, and priorities for multi-site operations. Regulatory Compliance & Audits Oversee compliance with FDA, ISO 13485, EU MDR, and other applicable quality and regulatory standards across all sites. Lead and coordinate preparations for internal, external, and regulatory audits; ensure timely resolution of audit findings and implementation of corrective actions. Provide leadership and support during regulatory inspections at any site, serving as the key point of contact for quality matters. Monitor and manage changes in regulatory requirements to ensure the company remains compliant across all locations. Quality Systems Management Drive the effectiveness of Quality Systems, including CAPA, document control, change management, non-conformance management, and risk management processes across all sites. Lead the standardization and optimization of quality processes to ensure alignment, efficiency, and compliance. Establish and monitor Quality Metrics/KPIs to track performance across all sites and drive improvements. Oversee the effectiveness of Management Review processes to ensure leadership alignment and continuous QMS improvements. Multi-Site Collaboration & Oversight Provide leadership, coaching, and mentorship to site Quality Managers and their teams, ensuring a consistent approach to quality practices and performance. Establish a structured approach for communication, collaboration, and knowledge sharing between sites to promote best practices. Partner with Operations, R&D, Manufacturing, and Supply Chain teams to ensure seamless integration of quality processes into all phases of product development and production. Act as a bridge between corporate leadership and site-level teams, ensuring company-wide quality objectives are understood and executed. Continuous Improvement Champion continuous improvement initiatives to reduce quality risks, improve operational efficiencies, and enhance product quality. Drive the implementation of Lean, Six Sigma, and other process improvement methodologies to standardize processes across sites. Analyze quality data and trends to identify opportunities for process improvements and cost savings. Product Development & Risk Management Provide quality oversight for new product development, ensuring proper design controls, risk management, and regulatory compliance. Ensure robust risk management strategies (e.g., FMEA, Hazard Analysis) are implemented and maintained across all product lines and sites. Collaborate with teams to resolve non-conformances, CAPAs, and customer complaints, driving resolution and prevention across sites. Leadership & Talent Development Build, mentor, and lead a high-performing quality team across all sites. Ensure appropriate training and development plans are in place for quality staff, fostering a culture of leadership and excellence. Promote accountability, ownership, and collaboration across all quality functions and teams. Required Qualifications Bachelor's degree in Engineering, Life Sciences, Quality Management, or related technical field. 10+ years of experience in Quality leadership roles within a regulated industry (e.g., medical devices, pharmaceuticals). Multi-site quality leadership experience, including developing and implementing global quality systems and strategies. In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable global regulations and standards. Strong experience with audits, regulatory inspections, and QMS improvement initiatives. Demonstrated success leading cross-functional teams, implementing process improvements, and harmonizing quality systems. Proven leadership skills, with experience mentoring and developing quality teams. Proficiency in quality tools and methodologies, including Lean, Six Sigma, and statistical analysis techniques. Excellent communication, organizational, and problem-solving skills. Preferred Qualifications Master's degree in a relevant field or an MBA. Certified Quality Engineer (CQE), Lead Auditor, or Six Sigma Black Belt certification. Experience with global operations and international regulatory compliance. Experience with ERP/QMS tools such as SAP, MasterControl, or similar platforms. Benefits Competitive salary and executive-level performance bonuses Comprehensive health, dental, and vision benefits 401(k) with company match Opportunities for professional development and career advancement Dynamic and collaborative work environment
US$180000 - US$200000 per year
Minnesota
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Principal Business Excellence Quality Engineer
Position Summary The Principal Business Excellence Quality Engineer is a key leadership role responsible for driving business process improvements, operational excellence, and quality initiatives across the organization. This position will leverage expertise in quality engineering, process improvement methodologies, and data-driven decision-making to optimize business performance, ensure regulatory compliance, and enhance overall efficiency. The role requires close collaboration with cross-functional teams, a strong understanding of quality systems, and the ability to identify and execute strategies that align with organizational goals. Key Responsibilities Operational Excellence & Process Improvement Lead Business Excellence initiatives by identifying opportunities for process optimization and operational efficiency across the organization. Utilize Lean, Six Sigma, and other process improvement tools to drive improvements, reduce waste, and enhance productivity. Lead cross-functional teams to execute process improvement projects, ensuring alignment with business objectives and measurable outcomes. Develop and implement Key Performance Indicators (KPIs) and metrics to monitor and measure process performance. Facilitate workshops, training, and process mapping exercises to drive a culture of continuous improvement. Quality Systems & Regulatory Compliance Ensure alignment and integration of quality system processes with business excellence initiatives. Support compliance with ISO 13485, FDA QSR, and other relevant regulatory standards by enhancing processes and systems. Evaluate current quality processes and systems to identify and implement improvements that enhance efficiency and compliance. Collaborate with Quality, Operations, and R&D teams to ensure processes meet regulatory, design, and manufacturing requirements. Risk Management Lead risk management efforts, including facilitation of Process Failure Modes and Effects Analysis (PFMEA) and Hazard Analysis to identify and mitigate potential risks. Drive the integration of risk management strategies into product and process development. Data Analysis & Decision Support Analyze complex data sets using statistical tools (e.g., hypothesis testing, DOE, regression, SPC) to identify trends, root causes, and opportunities for improvement. Provide data-driven insights and recommendations to leadership for improving business and quality system performance. Lead efforts to automate reporting processes for real-time monitoring and improved decision-making. Cross-Functional Leadership Collaborate with leadership and cross-functional teams (e.g., Quality, Operations, Supply Chain, R&D) to ensure alignment of business excellence initiatives with organizational goals. Mentor and train teams on process improvement methodologies, tools, and best practices. Serve as a change agent to foster a culture of quality, continuous improvement, and operational excellence. Strategic Planning Partner with executive leadership to define and execute Business Excellence strategies that drive long-term organizational success. Develop roadmaps for implementing business excellence projects, including timelines, resources, and success criteria. Monitor and communicate progress, ensuring accountability and alignment with company priorities. Required Qualifications Bachelor's degree in Engineering, Business, Quality Management, or related technical field. Master's degree preferred. 8+ years of experience in Quality Engineering, Operational Excellence, or Process Improvement roles within a regulated industry (e.g., medical devices, pharmaceuticals). Proven expertise in Lean Six Sigma methodologies (Black Belt certification preferred). Strong understanding of ISO 13485, FDA QSR, and other regulatory requirements. Demonstrated experience leading cross-functional process improvement projects with measurable outcomes. Proficiency in statistical analysis tools (e.g., Minitab, JMP, or equivalent) and data-driven decision-making techniques. Excellent project management, leadership, and facilitation skills. Strong communication, collaboration, and problem-solving abilities. Preferred Qualifications Certified Six Sigma Black Belt or Master Black Belt. Experience with ERP, QMS, and process automation tools. Knowledge of Design for Six Sigma (DFSS) or similar methodologies. Benefits Competitive salary and performance-based bonuses Comprehensive health, dental, and vision benefits 401(k) with company match Opportunities for professional development and career growth Dynamic, innovative, and collaborative work environment
US$130000 - US$150000 per year
Minnesota
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Sr. Quality Systems Engineer
Position Summary The Senior Quality Systems Engineer is responsible for developing, implementing, and maintaining Quality Management System (QMS) processes to ensure compliance with internal policies, regulatory standards (e.g., FDA, ISO), and global guidelines. This role focuses on document control, change management, CAPA, internal and external audits, and continuous improvement of quality systems. The ideal candidate will play a critical role in maintaining QMS effectiveness while driving quality excellence across the organization. Key Responsibilities Quality Management System (QMS) Oversight Implement, monitor, and maintain the effectiveness of the Quality Management System. Develop, review, and maintain QMS documentation, including Quality Operating Procedures (QOPs), work instructions, and records. Plan, lead, and execute internal audits to assess QMS effectiveness and ensure compliance with regulatory requirements. Prepare for and support external audits and inspections, addressing findings and driving corrective actions. CAPA Management Facilitate and manage Corrective and Preventive Action (CAPA) processes to identify root causes, implement solutions, and prevent recurrence. Monitor CAPA progress, ensure timely resolution, and evaluate effectiveness of actions taken. Document Control & Change Management Oversee document control systems, ensuring timely review, approval, and distribution of controlled documents. Manage change control processes, coordinating activities from initiation to implementation, while ensuring compliance with QMS requirements. Continuous Improvement Identify opportunities for QMS improvements to enhance efficiency and compliance. Support process improvements and standardization of quality system processes across the organization. Develop and maintain key quality metrics, reporting trends and proposing actions for improvement. Regulatory Compliance & Support Support Management Review activities by preparing data summaries and contributing to decision-making. Ensure compliance with FDA, ISO 13485, and other applicable regulatory and industry standards. Act as a quality resource for teams across the organization to ensure regulatory expectations are met. Training & Support Support quality system training programs by identifying needs and coordinating training sessions. Serve as a subject matter expert for quality system processes, providing guidance to cross-functional teams. Required Qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical field. 5+ years of experience in Quality Systems within the medical device or a highly regulated industry. Strong working knowledge of ISO 13485, FDA QSR, and other applicable regulatory standards. Experience with document control, CAPA, change management, and internal/external audits. Proficiency with quality tools and methodologies (e.g., risk management, root cause analysis, process improvement). Excellent analytical, organizational, and communication skills. Strong ability to collaborate across cross-functional teams and manage multiple priorities. Preferred Qualifications Certified Lead Auditor (ISO 13485) or experience conducting audits. Experience with quality management software systems (e.g., MasterControl, IMSXpress). Knowledge of process improvement methodologies (e.g., Lean, Six Sigma). Benefits Competitive salary and performance-based bonuses Comprehensive health, dental, and vision benefits 401(k) Opportunities for career growth and professional development
US$130000 - US$150000 per year
Minnesota
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Director of Quality Systems
Position Summary The Director of Quality Systems will play a key role in supporting this subsidary of one of the largest medical device companies in the world. There extensive experience in quality systems will be a needed in helping grow this medical device company. This position requires hands-on expertise in process validation, quality system management, and Endovascular experience! The ideal candidate is an experienced Manager/Director who thrives in a dynamic environment, can drive projects, lead a team, and provides mentorship to the team. Key Responsibilities Extensive experience in the medical device industry Endovascular (EVAR) experience Quality Management Systems expertise Oversee and maintain quality systems, including change control, CAPA, document control, and risk management processes (e.g., FMEA). Support internal and external audits, including preparation, response, and follow-up actions. Conduct gap assessments and remediation activities to ensure compliance with notified body and regulatory requirements (ISO 13485, FDA QSR, CE Mark). Lead quality system initiatives to improve efficiency and effectiveness. Qualifications Bachelor's degree in Engineering, Science, or a related technical field. Preferred: Experience supporting notified body audits and FDA inspections. Knowledge of supplier quality management and lean manufacturing principles. Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green Belt/Black Belt. Background in catheter manufacturing, process validations, or medical device product development.
US$185000 - US$225000 per year
San Jose
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Sr. Quality Engineer
Position Summary The Senior Quality Engineer will play a key role in supporting product development, process validations, and quality systems within a growing medical device company. This position requires hands-on expertise in process validation, quality system management, and continuous improvement initiatives to ensure compliance with industry standards and regulatory requirements. The ideal candidate is an experienced engineer who thrives in a dynamic environment, can drive projects independently, and provides mentorship to the team. Key Responsibilities Process Validation and Manufacturing Support Lead process validations, including protocol development and execution for IQ, OQ, PQ, and PPQ activities. Collaborate with R&D and manufacturing teams to implement robust, scalable processes that meet quality and regulatory standards. Identify and drive continuous improvement opportunities for product and process enhancements. Provide ongoing quality support for manufacturing, including addressing non-conformances and CAPA investigations. Quality Systems Management Oversee and maintain quality systems, including change control, CAPA, document control, and risk management processes (e.g., FMEA). Support internal and external audits, including preparation, response, and follow-up actions. Conduct gap assessments and remediation activities to ensure compliance with notified body and regulatory requirements (ISO 13485, FDA QSR, CE Mark). Lead quality system initiatives to improve efficiency and effectiveness. Cross-Functional Collaboration Partner with product development, manufacturing, and supply chain teams to drive quality throughout the product lifecycle. Provide quality expertise during design reviews, process improvements, and cost-saving initiatives. Collaborate with customer support teams to address and resolve customer complaints and feedback. Act as a quality liaison with suppliers to ensure compliance and address supplier quality issues. Leadership and Mentorship Serve as a mentor for junior engineers and technical staff, providing guidance and professional development support. Champion quality best practices and ensure alignment with company goals and objectives. Take initiative to identify opportunities for leadership and process improvements within the team. Qualifications Bachelor's degree in Engineering, Science, or a related technical field. Minimum 6-8 years of experience in a Quality Engineering role, preferably within the medical device industry. Proven expertise in process validation (IQ/OQ/PQ), risk management (FMEA), and statistical tools (DOE, SPC). Experience working within regulated environments (ISO 13485, FDA QSR, CE Mark). Strong knowledge of CAPA processes, quality systems management, and change control. Excellent communication skills, with the ability to interact cross-functionally and drive projects forward. Proficiency in quality tools and software (e.g., Minitab, QMS platforms). Preferred: Experience supporting notified body audits and FDA inspections. Knowledge of supplier quality management and lean manufacturing principles. Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green Belt/Black Belt. Background in catheter manufacturing, process validations, or medical device product development. Key Competencies Problem-Solving: Ability to analyze data, identify root causes, and implement effective corrective actions. Project Management: Strong organizational skills to manage multiple projects and timelines concurrently. Collaboration: Works well with cross-functional teams to achieve common goals. Leadership: Demonstrates initiative and the ability to guide teams to success. Attention to Detail: Ensures all processes and documentation meet high-quality standards.
US$130000 - US$150000 per year
Minnesota
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Principal Epidemiologist
We have a current opportunity for a Principal Epidemiologist on a permanent basis. The position can be remote with occasional travel to various site locations in the US (east and west coast). For further information about this position please apply. We're currently seeking a senior-level environmental or occupational epidemiologist to join our Health Sciences team as a Principal Epidemiologist. Applicants must have at least 15 years of experience in scientific consulting and demonstrated capability to develop new business. When you join us, you will provide technical and business leadership and will contribute to advanced solutions in the human health sciences with applications to the pharmaceutical, chemical, manufacturing, energy, government, and/or legal sectors. Your new role As our new Principal, you will focus on developing business that benefits from our technical expertise and global reputation. You must have experience in seeking and realizing opportunities and managing consulting assignments, enjoy and work effectively in multi-disciplinary teams, and be proficient in the analysis and communication of technical information. Your goal will be to work cooperatively with colleagues, agencies, and trade organizations to develop solutions that will guide risk-based decision-making. You must also demonstrate a commitment to mentoring and developing staff. Your primary practice or specialty areas may include one or more of the following: Regulatory science Product safety and stewardship Occupational health Expert services supporting the legal sector Community health and human health risk assessment Ramboll has adopted a hybrid model of work, with a combination of remote and in-person employee engagement. Regional, domestic, and international travel may be required for this position. Your new team As part of the Health Sciences team, you will be part of a creative group, filled with people who are really excited about solving clients' problems. You will work with all levels of technical expertise from new professionals to team members with decades of experience, many of whom are subject matter experts in their own fields. You will engage in a continual learning environment through coaching, mentoring, and on the job tasks. Your key tasks and responsibilities will include: Identifying and pursuing business opportunities Managing projects, clients, and regulatory agency relations Demonstrating thought leadership, through activities such as presenting and publishing scientific findings, testifying at administrative and/or court hearings, and participating in local, national, and international scientific and/or trade group meetings Collaborating with colleagues across disciplines and business units Guiding staff in their careers and promoting staff development About you While we look forward to supporting your continued learning and development, for this role we have identified some qualifications, skills, and capabilities that will set you up for success. These include: An academic degree in Epidemiology, or related discipline Book of Business 15+ years of experience in scientific consulting, including a track record of successful business development Strong written and oral communication skills Ability to manage diverse teams as well as external client and regulatory agency relationships Demonstrated leadership capabilities Demonstrated ability to generate revenues sufficient to support 2-3 staff members Personal qualities that will help you succeed in this role include: Being a confident communicator with superior management skills, having natural leadership talent, a collaborative attitude, the ability to motivate multidisciplinary teams across geographical borders, commitment to increasing equity, diversity, and inclusion in the workplace, and the motivation and ability to generate and maintain business to support company growth. What we can offer you The opportunity to work with some of the best and brightest professionals in your field and related fields Flexible work arrangements Generous Paid Time Off Excellent health and retirement benefits Investment in your development The long-term thinking of a foundation-owned company Inspiration from colleagues, clients, and projects
US$160000 - US$210000 per year
United States of America
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Site Head
About the Company - Our client is a top-tier global pharmaceutical company, driving medical innovations that shape healthcare outcomes globally. We are seeking a visionary Site Head to lead and inspire the site operations in Taiwan. This role is crucial in ensuring the highest standards of efficiency and quality, significantly contributing to the production of critical treatments for patients worldwide. About the Role - Site Head Key Responsibilities: Strategic Planning: Develop and implement long and short-term strategies, policies, and objectives to achieve company targets and business goals. Operational Excellence: Construct strategies for future business needs, participate in plant expansion planning, and ensure optimal performance in production, yield, safety, quality, and cost. Manufacturing Standards: Develop manufacturing plans, ensure resources and equipment are maintained, and implement methods to enhance product quality and safety. Cost Management: Achieve optimal staffing levels and control operational costs to meet budget plans, ensuring processes support business objectives. Continuous Improvement: Promote best practices, leverage Lean principles, and implement world-class manufacturing practices to boost efficiency and reduce waste. Team Leadership: Direct department managers, foster a culture of accountability, and maintain high employee morale through motivation and coaching. Staff Development: Hire, train, and evaluate staff, ensuring compliance with regulatory requirements and developing a high-performance workforce. Qualifications 10+ years of experience in the pharmaceutical industry. Proven experience with regulatory inspections, including US FDA and EMA. Strong leadership experience, managing over 200 full-time employees across production, manufacturing, and engineering teams. Ability to thrive under high pressure in a fast-paced environment. Language proficiency: Fluent in English and Mandarin preferred. Pay range and compensation package - Benefit from comprehensive relocation support and a competitive compensation package.
Negotiable
Taiwan
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Engineering Head
Our client is an international pharmaceutical company that specialises in development, manufacturing and commercialisation of drugs. THey are currently looking for an Engineering Head to lead the team in Taiwan. Key Responsibilities: Team Building and Management: Develop and lead a strong engineering team to manage and strategize capital projects. Oversee the life cycle of equipment and facilities, including site maintenance, system reliability, upgrades, and obsolescence management. Operational Oversight: Ensure all plant equipment is functioning normally, properly maintained, and calibrated. Oversee plans to maintain optimal equipment performance. Facilities and Utilities Management: Manage facilities and utilities operations to ensure they are operated and maintained under optimum safe conditions and in compliance with cGMP standards and regulations. Leadership and Development: Lead, coach, and empower team members to upgrade their skills and knowledge to meet new standards. Drive continuous improvement to adapt to new technologies and regulations. Planning and Coordination: Plan and coordinate site activities with other departments to ensure collaborative teamwork, achieving both short-term and long-term site goals. Key Requirements: Experience: More than 15 years of industry experience, with at least 8 years in management roles. Skills: Familiarity with process equipment and process engineering, particularly in oral solid dosage or softgel manufacturing. Knowledge: In-depth understanding of cGMP standards and regulations, and experience in managing facilities and utilities operations. Leadership: Strong leadership skills with a focus on team development and continuous improvement. Communication: Good communication skills. If you are interested, please apply with your updated CV attached.
Negotiable
Taiwan
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