Design Quality Assurance Specialist

3 weeks ago


Andover, Massachusetts, United States Smith & Nephew Full time
Job Summary

We are seeking a highly skilled Design Quality Engineer to join our team at Smith+Nephew. As a key member of our Quality Department, you will be responsible for providing Quality Engineering support for New Product Development activities in the Sports Medicine franchise.

Key Responsibilities
  • Support new product development and implementation of new hardware/software products via development of overall risk management files.
  • Participate in cross-functional core teams to provide quality input to product user needs, design inputs, software requirements, and design outputs.
  • Support design verification testing, design validation, and usability testing.
  • Develop and release engineering design documentation and support core teams during design reviews.
  • Assist in preparation for regulatory submissions and provide support during audits and inspections.
Requirements
  • B.S in Engineering or a technically related field.
  • 2-5 years Quality Engineering experience in Medical Device or regulated industry.
  • Risk Management per ISO 14971 preferred.
  • Medical device software development per IEC 62304 preferred.
  • ISO 13485 preferred.
What We Offer
  • 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement.
  • PTO, Paid Holidays, Flex Holidays, Paid Community Service Day.
  • Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program.
  • Hybrid Work Model (For most professional roles).
  • Hands-On, Team-Customized, Mentorship.
  • Discounts on fitness clubs, travel, and more.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.



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