Job Description Job Description
Job Title: Associate Quality Systems Specialist
Client: Medical Device Manufacturing Company
Duration: 11 Months Possibility of Extension
Location: Minneapolis, MN 55432
Shift: 1st Shift
Job Summary
The Associate Quality Systems Specialist will support site closure and quality system inactivation activities by processing change orders, conducting document impact assessments, coordinating document updates, and ensuring timely implementation of approved changes in compliance with company procedures and regulatory requirements.
Key Responsibilities
Process change orders and change control activities related to site closure and quality system inactivation.
Perform where-used assessments to identify impacted procedures, forms, specifications, records, and quality system documents.
Coordinate document updates, revisions, and obsolescence activities.
Support impact assessments and implementation of approved changes.
Track change orders and ensure completion within established timelines.
Maintain accurate records in the electronic Quality Management System (eQMS).
Collaborate with Quality, Operations, Engineering, Regulatory Affairs, and Document Control teams.
Prepare project status reports and provide updates on site closure activities.
Support quality system compliance, documentation maintenance, and applicable regulatory requirements.
Assist with quality reports, corrective and preventive actions (CAPA), and audit-related documentation as needed.
Required Skills & Qualifications
Experience with Change Control / Change Order Processing in a regulated environment.
Experience conducting document impact assessments and where-used reviews.
Familiarity with Quality Systems, Document Control, or eQMS processes.
Strong attention to detail and document accuracy.
Excellent organizational, time management, and communication skills.
Ability to manage multiple assignments and meet deadlines.
Proficiency in Microsoft Office applications.
Ability to analyze information and identify document impacts across quality systems.
Ability to work independently and collaborate with cross-functional teams.
Preferred Qualifications
Experience in medical device, pharmaceutical, biotechnology, or other regulated industries.
Familiarity with electronic Quality Management Systems (eQMS), such as Agile MAP.
Experience with quality systems and document control processes.
Internship, co-op, or academic project experience in Quality, Manufacturing, Engineering, Regulatory Affairs, or Document Control.
Exposure to regulatory compliance, audit preparation, CAPA documentation, or quality process improvement.
Education
Ideal Candidate
The ideal candidate is detail-oriented and organized, with experience in change control, document management, and quality systems within a regulated environment. They should be comfortable reviewing documentation for potential impacts, coordinating updates across teams, maintaining accurate eQMS records, and ensuring changes are implemented on time.
