Quality Engineer 2

Smith & Nephew; Town of Maple Plain (WI); Hybrid; USD 74,000 - 112,000; Full time

Benefits offered by this job

401k Matching Program

Discounted Stock Purchase Plan

Tuition Reimbursement

Medical Insurance

Parental Leave

Job summary

Smith+ Nephew is seeking a Quality Engineer II in Maple Plain, MN, to own manufacturing quality objectives and lead investigations into product and process issues. You will support sterile packaging and sterilization, apply lean quality principles, and collaborate across engineering, manufacturing, purchasing, and quality teams.

The role emphasizes hands-on quality support, cross-functional projects, and the ability to guide others while maintaining clear quality records in a regulated medical

Qualifications

• Bachelor's degree with at least 2 years of related experience; a four-year engineering degree is preferred.
• Experience leading investigations or corrective action projects in medical devices or regulated manufacturing.
• Working knowledge of inspection methods, drawings, measurement tools, sampling plans, quality documentation, and process controls.
• Experience across multiple manufacturing quality functions (receiving inspection, incoming quality control, supplier quality, sterile packaging, sterilization, process validation).
• Strong written and verbal communication; able to work independently with limited supervision.
• Must be able to lift up to 20 pounds.

Responsibilities

• Own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability.
• Lead investigations into quality events and develop corrective actions.
• Provide hands-on quality support for manufacturing processes including sterile packaging and sterilization.
• Lead cross-functional quality and continuous improvement projects.
• Partner with Manufacturing Engineering, Process Development, R&D, Purchasing and Quality to integrate quality into new lines.
• Monitor supplier and incoming material quality performance and support supplier corrective actions.
• Provide training and maintain quality records with regulatory compliance.

Skills

Investigation

Lean quality

Quality records

Sterile packaging

Education

Bachelor's degree in engineering

Four year engineering degree preferred

Tools

Inspection methods

Engineering drawings

Measurement tools

Process validation

Job description

Life. Unlimited. At Smith+ Nephew we design and manufacture technology that takes the limits off living. Join Integrity Orthopaedics, now part of Smith+ Nephew, as a Quality Engineer II in Maple Plain, Minnesota. This is an exciting opportunity to bring your quality engineering expertise to a growing medical device manufacturing operation, taking ownership of key quality activities while partnering across engineering, manufacturing, purchasing, and quality teams.

What will you be doing?

Independently own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability. Lead investigations into manufacturing and product quality events, including nonconformances, process issues, material discrepancies, and customer complaints, developing effective corrective and preventive actions. Provide hands on quality support for manufacturing processes, including sterile packaging and sterilization activities. Lead defined cross functional quality and continuous improvement projects, applying practical problem solving and lean quality principles. Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality requirements into new and expanding manufacturing lines. Monitor supplier and incoming material quality performance and support supplier corrective actions. Apply inspection methods, engineering drawings and specifications, measurement tools, sampling plans, and nonconforming material controls. Provide technical guidance and training support to less experienced team members and inspection personnel. Maintain clear, accurate, and timely quality records while supporting compliance with applicable regulatory requirements.

What will you need to be successful?

A bachelor's degree with at least 2 years of related work experience, or an equivalent combination of education and experience. A four year engineering degree is preferred. Experience independently leading investigations, improvement activities, or corrective action projects within medical devices or another regulated manufacturing environment. Working knowledge of inspection methods, engineering drawings, measurement tools, sampling plans, quality documentation, and manufacturing process controls. Experience across multiple manufacturing quality functions is preferred, particularly receiving inspection, incoming quality control, supplier quality, sterile packaging, sterilization, and process validation. Strong written and verbal communication skills, with the ability to work independently with limited supervision and provide technical guidance to others. The role requires the ability to lift up to 20 pounds.

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.

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.

Your Future

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Purchase Plan
• Tuition Reimbursement

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 74,250.00 - 111,500.00 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+ 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. Smith+N 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+N 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.