Quality Assurance - QA​/QC Coordinator

LHH is seeking a Quality Systems Coordinator II for a 6‑month onsite contract in Minnetonka. This role is essential in supporting the company’s quality and compliance framework by ensuring GxP records are organized, maintained, and easily accessible. The coordinator will play a key role in managing quality events, supporting complaint handling activities, and upholding the integrity of core Quality System processes.

The ideal candidate brings strong attention to detail, dependable follow‑through, and the ability to work cross‑functionally within a regulated environment.

• Coordinate day‑to‑day quality event workflows, monitor progress, and ensure activities align with internal procedures and compliance requirements.
• Classify, organize, and archive GxP records according to regulatory guidelines and internal retention schedules.
• Maintain both electronic and physical files to ensure accuracy, completeness, and traceability.
• Support the complaint handling process by entering product complaint information into the appropriate systems with a high level of accuracy.
• Assist with issuing, tracking, and maintaining controlled logbooks.
• Provide general support across multiple Quality System functions, including audits, CAPAs, document control, and training coordination.
• Perform other tasks as needed to help the department meet operational goals.

• High School Diploma or equivalent required; minimum 4+ years of experience in the medical device, life sciences, or similarly regulated industry.
• Hands-on experience with records management and an understanding of regulatory documentation requirements.
• Familiarity with Quality Management Systems such as Master Control or comparable platforms.
• Working knowledge of quality processes such as complaint handling, document control, and audit support.
• Understanding of applicable regulations, including GxP
  , 21 CFR
  , EU GMP
  , ICH
  , ISO
  , and QSR standards.
• Strong interpersonal skills with the ability to work effectively across different teams and levels of the organization.
• Demonstrated reliability, integrity, and a safety-first mindset.
• Self-motivated with a willingness to learn, take initiative, and contribute wherever needed.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers