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.
