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, Engineering, 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 consistent
execution 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 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?

• Support the maintenance of quality system records, including inspection records, batchdocumentation, and training records.

• Review Device History Records (DHRs) and acceptance records to verify completeness andcompliance with the Device Master Record (DMR).

• Ensure accurate, timely, and compliant completion of quality documentation across Operations.

• Support the change management process by assisting with Change Requests and relateddocumentation.

• Assist in the development and maintenance of work instructions and quality records that supportcompliant manufacturing and inspection activities.

• Reinforce quality requirements and expectations through daily interaction with Operationspersonnel.

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

• Assist with data collection, trending, and analysis of quality metrics to identify areas forimprovement.

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

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

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

What will you need to be successful?

• Postsecondary education and 3+ years of experience in a medical device or other regulatedmanufacturing environment

• Experience working within a document-controlled quality system, including change control orcontrolled documentation processes

• Ability to clearly document work, observations, and issues using approved forms, records, andprocedures

• Good written and verbal communication skills, with the ability to interact effectively withOperations, Quality, and Engineering 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 proven ability to successfully work with minimal supervision

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 $50,000 - $75,000 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.