Associate Quality Systems Specialist

An exciting opportunity is available for an Associate Quality Systems Specialist to support site closure activities within a regulated environment. This role is based onsite in Rice Creek, MN and requires local residency. The successful candidate will process change orders related to site closure and quality system inactivation, execute where-used assessments to identify impacted documents, and coordinate updates and obsolescence activities.

You will ensure timely implementation of quality system changes in compliance with internal procedures and regulatory requirements.

Key responsibilities include tracking change order progress, supporting impact assessments, and collaborating with cross-functional teams such as Quality, Operations, Engineering, Regulatory Affairs, and Document Control. Maintaining accurate records within the electronic Quality Management System (eQMS) and supporting project reporting are essential aspects of this role. The position also requires ensuring compliance with applicable regulations and company requirements.

Candidates must hold a bachelor's degree and possess broad theoretical job knowledge, typically acquired through advanced education. While no prior experience is strictly required, a minimum of two years of relevant experience is preferred. Internship, co‑op, or academic project experience in Quality, Manufacturing, Engineering, Regulatory Affairs, or Document Control is advantageous. Familiarity with quality systems, document control, and eQMS processes‑especially within Medical Device, Pharmaceutical, Biotechnology, or other regulated industries is highly valued.

Strong attention to detail, excellent organizational and time management skills, and the ability to manage multiple assignments and meet deadlines are essential. Proficiency in Microsoft Office and strong written and verbal communication skills are required. The ideal candidate will be able to analyze information, identify document impacts, and work both independently and collaboratively within cross-functional teams.

• Change Control
• Change Order processing
• document impact assessments
• where‑used reviews
• Quality Systems
• Document Control
• eQMS

• Agile MAP
• Medical Device industry
• Pharmaceutical industry
• Biotechnology industry
• Manufacturing industry
• Microsoft Office
• attention to detail
• organizational
• time management
• written communication
• verbal communication
• analyzing information
• collaborative working

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.