Title: Senior Design Quality Engineer
Summary: A leading multi-million dollar medical device manufacturer is seeking an experienced senior design quality engineer to join their team in their Massachusetts location. This is a rapidly growing company with multiple FDA approvals making big changes in the med-device industry. You will be responsible for the design control process and assuring NPI's and regulatory requirements are met. This role supports the quality management team and reports to the Senior Director of Quality Assurance. If you are a detail oriented, motivated, and organized individual we encourage you to apply.
The Senior Design Quality Engineer will be responsible for:
- Effectively achieve design control requirements
- Create and improve processes for internal/external regulations and standards
- Provide design input and review DHF files for accuracy
- Partner with Development and Engineering departments to ensure success
- Other tasks as required
Qualifications:
- Minimum 8 years of related experience within this field
- Experience with Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV)
- Medical device development experience required
- Working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971
- Knowledge of software development lifecycle
- Experience with statistical analysis tools is preferred
Benefits/Perks:
- Free parking
- Free gym
- Competitive PTO and 401K package
- Onsite cafeteria and Starbucks
If you are interested in the Senior Design Quality Engineer role, don't hesitate to apply today!
