What are the responsibilities and job description for the Quality Engineer / Project Lead - medical devices position at InnoTech Staffing?
Job Description
Job Description
InnoTECH Staffing is looking to hire a Quality Engineer / Project Lead for a product development company in Southern New Hampshire. This is onsite 5 days a week. No sponsorship at this time.
We are seeking a Lead Project Quality Engineer to provide Quality Leadership on a dynamic, fast paced medical device research and development team.
How you will make an impact as a Lead Project Quality Engineer :
- Work cooperatively with cross functional design team leads and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485 : 2016
- Use experience within product development or production of medical devices, to provide guidance and assistance in the development of new products.
- Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
- Participate in and lead Risk Management activities in accordance with ISO 14971 : 2019, such as;
Reviewing and approving Risk Management Plans
Coordinate the efforts of individuals and teams performing investigations.
Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies.
How you will be successful in this role as a Lead Project Quality Engineer :
A degree in a related STEM discipline (Physics, mathematics, etc.) may be considered with sufficient professional experience.
Experience in new product development strongly preferred.
Experience supporting EU fielded product is a plus.
