Quality Technician (Maple Plain, MN)

Quality Technician (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 Technician to join Integrity Orthopaedics, a recently acquiredmedical device startup now part of Smith & Nephew. With the backing and resources of a globalorganization, 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.

The Quality Technician will be a key member of the Quality team, providing day-to-day quality supportacross Operations, including receiving inspection, manufacturing, and warehouse activities. This roleworks closely with Manufacturing, R&D, Supply Chain, and Quality/Regulatory to ensure product quality,compliance, and continuous improvement throughout the production lifecycle.

This position is ideal for a hands-on, detail-oriented individual who enjoys working directly on themanufacturing floor, addressing issues as they arise, and partnering with Operations to ensure consistentexecution of quality requirements. The Quality Technician plays a critical role in investigatingnonconformances, supporting corrective actions, reinforcing quality requirements, and acting as a visiblechampion of the site's quality culture. In addition, this individual may support R&D by assisting in theevaluation of new product designs or design updates through dimensional inspections, deviceevaluations, and other activities that help ensure design intent and product performance.

In all actions, this person shall demonstrate a primary commitment to patient safety and product quality bymaintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What will you be doing?

• Provide advanced support for the maintenance of quality system records, including inspectionrecords, batch documentation, and training records.

• Lead reviews of Device History Records (DHRs) and acceptance records to verify completenessand compliance with the Device Master Record (DMR), identifying trends or systemic issuesrequiring corrective action.

• Ensure accurate, timely, and compliant completion of quality documentation across Operations,proactively identifying gaps and driving improvements in documentation practices.

• Assist in the development, improvement and maintenance of work instructions and qualityrecords that support compliant manufacturing and inspection activities.

• Reinforce and elevate quality requirements through daily interaction with Operations personnel,providing mentorship, coaching, and guidance to lowerlevel technicians and operators.

• Support identification, documentation, and investigation of nonconformances and quality issues.

• Perform data collection, trending, and analysis of quality metrics to identify risks and areas forimprovement.

• Participate in continuous improvement initiatives focused on quality, compliance, and operationaleffectiveness.

• Support internal and external audits by retrieving documents and records and supporting on-siteaudit activities.

• May support R&D by assisting in the evaluation of new product designs or design updatesthrough dimensional inspection, device evaluations, test method execution, and other activitiesthat ensure design intent, manufacturability, and product performance.

• May support inspections in receiving by helping set up and run inspection equipment, creatingbasic inspection routines, and ensuring incoming materials are inspected accurately andconsistently according to specifications.

• Ensure daily activities comply with company policies, procedures, and applicable quality systemrequirements.

What will you need to be successful?

• Postsecondary education and 8+ years of experience in a medical device or other regulatedmanufacturing environment.

• Strong ability to clearly document work, observations, test results, and issues using approvedforms, records, and procedures.

• Good written and verbal communication skills, with the ability to interact effectively withOperations, Quality, and R&D teams.

• Highly organized, accountable, and strong attention to detail.

• Proven ability to prioritize multiple tasks, meet deadlines, and maintain quality and compliance ina fast-paced setting.

• Self-starter with a track record of working independently with minimal supervision.

Preferred Qualifications

• Experience supporting receiving inspection, inprocess inspection, or final inspection, includinguse of measurement tools, inspection equipment, or basic inspection programming.

• Experience supporting nonconformance investigations, root cause analysis, or corrective actionactivities.

• Familiarity with R&D support activities, including dimensional inspection, device evaluation, ortest method execution.

• Experience mentoring or guiding junior technicians or operators.

• Ability to perform basic programming and setup of automated/semiautomated inspectionequipment, including creation or adjustment of simple inspection routines.

• Strong analytical skills with experience performing data reviews, trending, or quality metricanalysis.

Other: Ability to lift up to 20 pound

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 $65,000 - $97,500 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.