Job Title: Quality Systems Contractor

Work Location: Hennepin County, Minnesota

Summary:

Seeking a Quality Systems Contractor for a 6-week contract to support and maintain compliance within Quality Systems. This role focuses on managing GxP records, supporting quality event processes, and ensuring regulatory standards are met. The position requires strong organizational skills, attention to detail, and the ability to collaborate across teams.

Responsibilities:

• Oversee and track quality event processes to ensure compliance with regulatory and internal standards.
• Sort, categorize, and manage records in accordance with retention schedules and regulatory requirements.
• Maintain both physical and electronic records for accuracy, accessibility, and traceability.
• Support the complaint handling process by entering and managing product complaint data.
• Assist in the maintenance and issuance of controlled logbooks for quality documentation.
• Provide support for audits, CAPAs, document control, and training activities within Quality Systems.
• Collaborate with cross-functional teams to uphold quality and regulatory standards.
• Perform additional tasks as needed to support departmental and organizational objectives.

Qualifications:

• High School Diploma or equivalent with 4+ years of experience in the life sciences or medical device industry.
• Strong background in records management and regulatory compliance.
• Experience with MasterControl or similar Quality Management Systems (QMS).
• Broad knowledge of Quality functions, including customer complaint processes.
• Familiarity with GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards.
• Demonstrated integrity, self-confidence, and commitment to prioritizing customer and patient safety.
• Excellent interpersonal and collaboration skills across all organizational levels.
• Proactive work ethic, eagerness to learn, and willingness to take on new responsibilities.

Published Category: Quality & Validation