This position will be responsible for leading quality engineering activities associated with new product development, quality systems and risk management on devices. In addition, this individual will serve as a mentor to help lead and train junior engineers within the team.
Our latest client is a privately-held OEM, Class III medical device manufacturer based in the Andover MA area. This company has three major devices which are commercialized in Europe, Canada, and Australia and has recently been FDA-approved for commercialization in the United States.
- Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk management, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
- Conduct investigations to identify root cause of problems and implement effective corrective actions. Participate in internal audits and suppliers evaluations. Defines and establishes needed quality initiatives. Develop quality system procedures through cross-functional teams.
- Train and coach DQEs and Associate DQEs. Provide training and business process expertise within and outside the quality department. Provide support to other Global Quality projects as needed
- Support the applicable site Quality System.
- Bachelor's Degree (B.S.) in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university
- Minimum of five (5) years of Quality Engineering experience in the medical device industry
- Working knowledge and practical application of Design Controls and experience with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, IEC 60601-1 and MDD.
- Experience in product development with complex medical systems (mechanical, electrical, software, chemistry)
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Strong base salary
- Lead role - this individual will serve as the Lead Senior Quality Engineer to support New Product Development projects
- Life-saving, Class III Medical Device
- Leads and mentors junior engineers with opportunity for growth
- Competitive benefits package
- Ample opportunity for promotions
- Market leader with top ratings