Quality Technician (Maple Plain, MN)

Smith+Nephew•Maple Plain, MN

2d•$65,000 - $97,500•Onsite

About The Position

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 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. The Quality Technician will be a key member of the Quality team, providing day-to-day quality support across Operations, including receiving inspection, manufacturing, and warehouse activities. This role works 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 the manufacturing 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 investigating nonconformances, supporting corrective actions, reinforcing quality requirements, and acting as a visible champion of the site’s quality culture. In addition, this individual may support R&D by assisting in the evaluation of new product designs or design updates through dimensional inspections, device evaluations, 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 by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Requirements

Postsecondary education and 8+ years of experience in a medical device or other regulated manufacturing environment.
Strong ability to clearly document work, observations, test results, and issues using approved forms, records, and procedures.
Good written and verbal communication skills, with the ability to interact effectively with Operations, 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 in a fast-paced setting.
Self-starter with a track record of working independently with minimal supervision.
Ability to lift up to 20 pound

Nice To Haves

Experience supporting receiving inspection, in‑process inspection, or final inspection, including use of measurement tools, inspection equipment, or basic inspection programming.
Experience supporting nonconformance investigations, root cause analysis, or corrective action activities.
Familiarity with R&D support activities, including dimensional inspection, device evaluation, or test method execution.
Experience mentoring or guiding junior technicians or operators.
Ability to perform basic programming and setup of automated/semiautomated inspection equipment, including creation or adjustment of simple inspection routines.
Strong analytical skills with experience performing data reviews, trending, or quality metric analysis.

Responsibilities

Provide advanced support for the maintenance of quality system records, including inspection records, batch documentation, and training records.
Lead reviews of Device History Records (DHRs) and acceptance records to verify completeness and compliance with the Device Master Record (DMR), identifying trends or systemic issues requiring 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 quality records that support compliant manufacturing and inspection activities.
Reinforce and elevate quality requirements through daily interaction with Operations personnel, providing mentorship, coaching, and guidance to lower‑level 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 for improvement.
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.
May support R&D by assisting in the evaluation of new product designs or design updates through dimensional inspection, device evaluations, test method execution, and other activities that ensure design intent, manufacturability, and product performance.
May support inspections in receiving by helping set up and run inspection equipment, creating basic inspection routines, and ensuring incoming materials are inspected accurately and consistently according to specifications.
Ensure daily activities comply with company policies, procedures, and applicable quality system requirements.