Design Quality Assurance Specialist
3 weeks ago
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.
- 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.
- 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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