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Design Quality Engineer

Smith+Nephew

Skills

Required

  • Design Control and requirements
  • FDA CFR 820
  • ISO 13485
  • EU MDR
  • GxP
  • Excel
  • AI tools

Preferred

  • statistical background
  • design verification
  • validation
  • sterilization validation
  • process validation
  • supplier qualification
  • test methods
  • risk management documentation

About Smith+Nephew

  • Life. Unlimited.
  • You. Unlimited.
  • We believe in creating the greatest good for society.
  • Our strongest investments are in our people and the patients we serve.
  • We're more than just a company - we're a community!
  • Explore our website and learn more about our mission, our team, and the opportunities we offer.

Responsibilities

  • Support design controls and quality activities, including design verification and validation, sterilization validation, process validation, supplier qualification, test methods, capability studies and risk management documentation.
  • Develop methods and procedures that help ensure products meet required specifications and standards, with product safety and reliability established through appropriate testing.
  • Support manufacturing operations with expertise in product requirements, risk management, test methods and statistical analysis.
  • Help ensure compliance with applicable quality and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.
  • Partner with external laboratories and suppliers to communicate product and process requirements and assess capabilities.
  • Support continuous improvement activities, including CAPA, nonconformance and internal audit activities.
  • Contribute to Post Market Surveillance, Management Review and audit and inspection activities.

Requirements

  • Bachelor’s degree in Engineering.
  • 0 to 2 years of experience in the medical device or a related industry, with a general or basic understanding of Design Control and requirements such as FDA CFR 820, ISO 13485, EU MDR and GxP.
  • Ability to manage and prioritize multiple projects, tasks and deadlines while working effectively as part of a team.
  • Effective written and verbal communication skills, with proficiency in Excel and AI tools.
  • Ability to travel less than 5% Before applying, please note that this position is not eligible for employer-sponsored immigration support.
  • Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization .

Preferred

  • A statistical background is preferred.

Benefits

  • Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website.
  • Your Future
  • 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more!

Equal opportunity

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.

Stay connected

  • Stay connected by joining our Talent Community .
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  • Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N.

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