Quality Technician (Maple Plain, MN)

Smith+NephewMaple Plain, MN
1d$50,000 - $75,000Onsite

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, 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 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 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 3+ years of experience in a medical device or other regulated manufacturing environment
  • Experience working within a document-controlled quality system, including change control or controlled documentation processes
  • Ability to clearly document work, observations, and issues using approved forms, records, and procedures
  • Good written and verbal communication skills, with the ability to interact effectively with Operations, 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 in a fast-paced setting
  • Self-starter with proven ability to successfully work with minimal supervision
  • Ability to lift up to 20 pounds

Responsibilities

  • Support the maintenance of quality system records, including inspection records, batch documentation, and training records.
  • Review Device History Records (DHRs) and acceptance records to verify completeness and compliance 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 related documentation.
  • Assist in the development and maintenance of work instructions and quality records that support compliant manufacturing and inspection activities.
  • Reinforce quality requirements and expectations through daily interaction with Operations personnel.
  • Support identification, documentation, and investigation of nonconformances and quality issues.
  • Assist with data collection, trending, and analysis of quality metrics to identify 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.
  • Ensure daily activities comply with company policies, procedures, and applicable quality system requirements.

Benefits

  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • Flexible Personal/Vacation Time Off
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision
  • Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hybrid Work Model (For most professional roles)
  • Hands-On, Team-Customized, Mentorship
  • Discounts on fitness clubs, travel and more!
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