The Senior Quality Engineer is responsible for supporting the Smith & Nephew new product development activities.
The Senior Quality Engineer will ensure that the Regulations, Standards and Guidelines are complied with ensuring that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).
Knows and adheres to the quality policy of the company and the quality-related procedures and instructions.
Supports new product development to deliver safe and effective products to the market by ensuring all aspects of design controls are robust and comply with company polices and governmental regulations. Key design control deliverables include but are not limited to: risk management, product performance analysis on similar products, design verification / validation, design transfer to manufacturing, DHF tracking and completion, and product release authorization for distribution.
Subject matter expert for technical design reviews - responsible for compiling and presenting the quality data to key stakeholders/ leadership during technical design reviews.
Lead design control gap assessments (DHF audits) and remediation as required
Assist in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits.
Works cross-functionally to influence key stakeholders and provides training, leadership and mentorship to teams and junior QEs
Location: Mansfield, MA
Education: B.S. Engineering or equivalent experience.
Licenses/ Certifications: CQE desirable, Risk Management
Experience: 7- 10 years related experience. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485.
Time management, ability to plan and schedule multiple projects and tasks
Effective written/oral communication skills
Weight Lifting: Light (0kg - 5kg)
Position: Mostly sitting
Repetitive Motion: Mostly computer use
Chemical Exposure: Alcohol or cleaning agents only.
Physical Risk (Personal Protective Equipment – PPE): frequent use of PPE required per company policies