What are the responsibilities and job description for the Quality Engineer - medical devices position at InnoTech Staffing?
Job Description
Job Description
InnoTECH Staffing is looking to hire a Quality Engineer for a product development company in Southern New Hampshire.
This is onsite 5 days a week. No sponsorship at this time.
We have an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality Manager. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment.
How you will make an impact :
- Work cooperatively with cross functional design team members 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
- Participate in and lead Risk Management activities in accordance with ISO 14971
- The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation.
- Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills.
- Coordinate the efforts of individuals and teams performing investigations.
- Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA.
- Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
- Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies.
- Prepare detailed work plans and procedures such as Validation Plans.
- Evaluate and approve proposed design or manufacturing process change.
- Drive system and process improvements.
- Provide reliability and statistical analysis.
- Participate in internal and external audits.
How you will be successful in this role :
Multitask and carry tasks through to completion
