Manufacturing Quality Engineer (Maple Plain, MN)

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Maple Plain, MN, USA
In-Office
74K-112K Annually
Senior level
Healthtech • Biotech
The Role
Lead manufacturing quality and compliance for scaling medical device production. Drive continuous improvement, investigate and resolve nonconformances, support sterile packaging and sterilization processes, manage supplier quality, and partner cross-functionally to embed robust, scalable quality systems.
Summary Generated by Built In

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.

What will you be doing?

  • 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.

What will you need to be successful?

  • 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.

Preferred Qualifications

  • 4 year engineering degree Job Description – Quality Engineer II.

  • Experience owning cross functional improvement and corrective action projects.

  • Demonstrated project management success.

Other: Ability to lift up to 20 pounds

You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

  • Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/).

  • Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, 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!  

#LI-ON-SITE

"The anticipated base compensation range for this position is $74,250 - $111,500 USD annually.

The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.  Compensation decisions are dependent upon the facts and circumstances of each position and candidate.  

In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings. "

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 by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

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.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

 

Top Skills

Capa
Lean
Sterile Packaging
Sterilization
Supplier Quality Management
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The Company
Andover, MA
15,318 Employees

What We Do

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win.. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Please note: not all products referred to may be approved for use or available in all markets.

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