Senior 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 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 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 independently drives practical problem-solving on the manufacturing floor. This position offers a unique blend of startup pace and ownership, 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?
Own and drive objectives related to manufacturing product performance, quality, and compliance in a fast-paced, scaling production environment.
Lead and actively participate in lean quality and continuous improvement initiatives, fostering engagement across manufacturing, engineering, and quality teams.
Investigate, own, and resolve manufacturing and product quality events, including nonconformances, process issues, and customer complaints, driving effective corrective and preventive actions.
Provide hands-on quality support for critical manufacturing processes, including sterile packaging and sterilization activities, ensuring robust, compliant, and scalable processes.
Partner closely with Manufacturing Engineering, Process Development, and R&D to embed quality into new and expanding manufacturing lines.
Monitor supplier performance metrics and lead corrective actions to address quality or delivery discrepancies.
Provide technical guidance and practical problem-solving leadership, working cross-functionally to identify, assess, and resolve manufacturing and quality challenges.
Ensure ongoing compliance with company quality policies, procedures, and applicable regulatory requirements, with a strong focus on patient safety and product quality.
What will you need to be successful?
This position does not offer visa sponsorship now or in the future
Minimum Qualifications
Bachelor's degree plus a minimum of 5+ years of related work experience or an equivalent combination of education and work experience
Experience owning cross functional improvement and corrective action projects
Self-starter with proven ability to successfully work with minimal 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
Experience supporting multiple Quality functions
Demonstrated project management success
Other
Ability to lift up to 20 pounds
Schedule is on 1st shift, Monday - Friday, onsite.
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!
The anticipated base compensation range for this position is $96,750 - $145,000 UD 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.
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