Title:
Quality Systems Coordinator II
Pay:$24.00-$28.00/hour
Location:
Minnetonka, MN
Duration:
5-Month Contract
Schedule:
Monday–Friday, 9:00 AM – 5:00 PM (Standard Business Hours)
Job Summary
The Coordinator II, Quality Systems
plays a key role in maintaining regulatory compliance and supporting the integrity of Quality Systems within a regulated environment. This position is responsible for ensuring GxP records are properly managed and accessible, while contributing to the effectiveness of core quality processes. Primary areas of focus include quality event management and support of complaint handling activities.
The role requires strong attention to detail, excellent organizational skills, and the ability to collaborate cross-functionally to uphold regulatory standards and internal procedures.
Essential Functions and Responsibilities
Responsibilities include, but are not limited to:
- Administer and monitor quality event processes, ensuring conformance to established standards and tracking operational performance.
- Sort, categorize, and manage records in alignment with retention schedules, regulatory requirements, and internal procedures.
- Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability.
- Support complaint handling processes by accurately entering product complaint data into the quality system.
- Assist with the maintenance, control, and issuance of controlled logbooks.
- Provide support across Quality System areas, including audits, CAPAs, document control, and training activities.
- Perform additional duties as assigned to support departmental and organizational objectives.
Education, Experience, Knowledge, Skills, and Abilities
Education & Experience
- High School Diploma or equivalent required.
- Minimum of 4 years of experience in the life sciences or medical device industry.
Knowledge & Technical Skills
- Strong foundation in records management and regulatory compliance.
- Familiarity with MasterControl or similar Quality Management Systems.
- Broad experience across Quality functions, including customer complaint processes.
- Working knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards.
Professional Competencies
- Demonstrates integrity, self-confidence, and a strong commitment to customer and patient safety.
- Excellent interpersonal and communication skills; able to collaborate effectively across all organizational levels.
- Strong organizational skills with exceptional attention to detail.
- Proactive and dependable work ethic with a willingness to learn, take on new responsibilities, and support additional tasks as needed.
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