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Principal Design Quality Engineer - Medical Device
Seeking degreed biomedical design quality engineers with 7+ years of experience.
Our latest client is a publicly held medical instruments manufacturer.
About Our Client
Our latest client is a publicly held medical instruments manufacturer headquartered in the Milford MA area.
- 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
The Successful Applicant
- 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 and a minimum of seven (7) years related experience.
- Experience in the application of design controls and risk management in an IVD or Medical device industry.
- Experience in product development with complex systems (mechanical, electrical, software, chemistry)
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
- Experience representing their department during quality system audits.
What's on Offer
- Strong base salary
- New Design Quality Department. This position will help drive a new organizational structure.
- Competitive benefits package
- Mentor role with opportunity to become a manager
- Market leader with medical device type