Manufacturing Quality Engineer (Maple Plain, MN)

Smith+NephewMaple Plain, MN
2dOnsite

About The Position

Manufacturing Quality Engineer (Maple Plain, MN) Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This is an exciting opportunity for a Manufacturing Quality Engineer to join Integrity Orthopaedics, a recently acquired medical device startup now part of Smith & Nephew. With the backing and resources of a global organization, Integrity Orthopaedics is focused on scaling its manufacturing operations at its Maple Plain, Minnesota site while maintaining the agility and hands-on culture of a startup. This role is ideal for a well-rounded quality engineer who thrives in a dynamic, fast-growing manufacturing environment and is energized by building and scaling processes. The Manufacturing Quality Engineer will be a key partner to Manufacturing Engineering, R&D, and Process Development, helping to embed quality into expanding production lines while supporting continuous improvement activities across the site. The ideal candidate is a hands-on quality engineer who takes ownership, applies lean quality principles, and drives practical problem-solving on the manufacturing floor. This position offers a unique blend of startup pace, combined with the structure, standards, and support of a larger medical device organization. In all actions, this person shall demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Requirements

  • Bachelor's degree plus a minimum of 2+ years of related work experience or an equivalent combination of education and work experience.
  • Self-motivated and capable of managing day-to-day responsibilities with moderate supervision.
  • Multitasks, prioritizes, and meets deadlines in timely manner with high attention to detail.
  • Medical Device or regulated industry experience.
  • Good written and oral communication skills.
  • Highly organized, accountable, and strong attention to detail.
  • Ability to lift up to 20 pounds

Nice To Haves

  • 4 year engineering degree
  • Experience owning cross functional improvement and corrective action projects.
  • Demonstrated project management success.

Responsibilities

  • Support and contribute to objectives related to manufacturing product performance, quality, and compliance in a fast-paced, scaling production environment, escalating issues when needed.
  • Participate in lean quality and continuous improvement initiatives, collaborating across manufacturing, engineering, and quality teams to help identify opportunities and implement improvements.
  • Investigate and assist in resolving manufacturing and product quality events, including nonconformances, process issues, and customer complaints, while contributing to effective corrective and preventive actions.
  • Provide hands-on quality support for key manufacturing processes, including sterile packaging and sterilization activities, helping maintain robust, compliant, and scalable processes.
  • Work closely with Manufacturing Engineering, Process Development, and R&D to support and integrate quality into new and expanding manufacturing lines.
  • Monitor supplier performance metrics and support corrective actions to address quality or delivery discrepancies.
  • Provide technical support and contribute to practical problem-solving efforts, collaborating cross functionally to help identify, assess, and resolve manufacturing and quality challenges.
  • Maintain compliance with company quality policies, procedures, and applicable regulatory requirements, consistently supporting a culture of patient safety and product quality.

Benefits

  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • Flexible Personal/Vacation Time Off
  • 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)
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