Title: Senior Quality Assurance Engineer
Summary: A leading medical contract manufacturer is currently seeking a diligent and knowledgeable Senior Quality Assurance Engineer to lead their southern Massachusetts headquarters. You will be responsible for assisting in the identification of best practices for the organization's wide range of custom specialty medical devices and demonstrate exceptional understanding of FDA 21, CFR 820, and ISO 13485.
The Senior Quality Assurance Engineer will…
- Coordinate CAPA and NCMR meetings and investigate root causes in collaboration with the Auditors, Manufacturing Supervisors and Engineers.
- Develop programs for maintenance, replacement and improvement of inspection techniques, gage R and R and new electronic collection and data reduction techniques.
- Perform internal and external audits as required, including pre-audit preparation, and assisting with post audit communication.
- Mentor Quality staff and multiple discipline teams in problem solving and root cause techniques.
The Senior Quality Assurance Engineer should have the following qualifications:
- BS/BA in Engineering, Quality, or Manufacturing
- Minimum 7+ years in Medical Device manufacturing
- Experience with FDA 21, CFR 820, and ISO 13485
- Risk Management skills (e.g., FMEA and ISO 14871)
- Medical insurance
- Dental insurance
- Disability insurance
If you are interested in the Senior Quality Assurance Engineer role, then please don't wait to apply!