Quality Technician

We are seeking a detail-oriented and experienced Quality Technician I and Quality Technician II, to support and strengthen our Quality Management System (QMS) within a regulated manufacturing environment. This role is responsible for leading nonconforming material events, conducting in-process production documentation audits, and ensuring the accuracy and completeness of quality records in compliance with Good Manufacturing Practices (GMP), ISO standards, and medical device requirements.

The ideal candidate is a proactive problem-solver with strong quality systems experience, exceptional organizational skills, and the ability to collaborate effectively across departments to drive continuous improvement and regulatory compliance.

This position is a direct placement with our client in Brooklyn Park, MN.

Essential Responsibilities

• Create, revise, and maintain Quality Management System (QMS) procedures and documentation.
• Support the implementation and continuous improvement of quality systems and processes.
• Develop and implement plans to ensure ongoing QMS compliance.
• Support compliance with GMP, ISO 9001/13485, and medical device quality requirements.
• Assist with issue resolution and system administration activities within Quality Management software.
• Conduct production line audits and manufacturing documentation audits.
• Lead periodic cross-functional reviews of line and paperwork audit programs.
• Document audit findings and communicate results to Operations and Quality teams.
• Maintain accurate quality records and ensure timely reporting of findings.
• Work collaboratively with Operations and Quality teams to resolve manufacturing documentation issues.
• Lead Non-Conforming Material Report (NCMR) events and Material Review Board (MRB) meetings.
• Support management of the MRB Cage and disposition activities.
• Assist with the issuance, investigation, and closure of Non-Conformance Reports, Complaints, and Corrective and Preventive Actions (CAPAs).
• Support CAPA investigations, action implementation, and effectiveness evaluations.
• Provide management with status updates related to NCMRs, audits, and corrective actions.
• Assist with internal, customer, and third-party audits, including preparation, execution, reporting, and follow-up.
• Identify quality system gaps and drive process improvements using Lean methodologies.

Qualifications

• High school diploma or GED.
• Minimum of 5 years of experience in a quality-related role within a manufacturing environment.
• Strong understanding of quality systems, inspections, and manufacturing processes.
• Experience using inspection equipment and performing equipment maintenance.
• Strong problem-solving and analytical skills.
• Ability to manage multiple priorities and meet deadlines.
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint, Publisher).
• Mechanical aptitude and manual dexterity.
• Ability to use microscopes, measuring devices, and hand tools.
• Associate degree or equivalent combination of education and experience.
• 5 years of quality assurance experience.
• Working knowledge of ISO 9001 and ISO 13485 requirements.
• Quality Technician, Quality Assurance, or related industry certifications.
• ISO 13485 Internal Auditor Certification.
• Experience with quality systems in a regulated manufacturing environment.
• Demonstrated commitment to professional development and ongoing education through industry associations, training, or certification programs.

Payrates and Schedules

• Quality Technician I: $23.08 - $33.46
• Quality Technician II: $25.16 - $33.49
• First shift 6:00am to 2:30pm Monday through Friday

Benefits

• Health care insurance benefits available first of the month following 60 days of employment. Thirty (30) hours worked per week must be averaged in order to maintain coverage. 401k enrollment is available per the Secure Act guidelines. Earned Sick and Safe time is accrued and can be used per the State of MN guidelines. #IND345