Quality Systems & Document Control Lead

ADP, Inc.; Plymouth (MN); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

401k match

Profit sharing

Medical insurance

HSA / FSA

Vision insurance

Life insurance

Family medical leave

Long-term disability

Hospital indemnity

Critical Illness insurance

Identity theft protection

Pet insurance

Job summary

ProMed is seeking a Quality Systems Specialist to manage the day-to-day document control within the Quality Management System, ensuring ISO 13485 and FDA 21 CFR 820/Part 11 compliance. You will drive continuous improvements in the QMS to support manufacturing operations and audit readiness.

The role involves overseeing change management, training coordination, and ensuring controlled documents are current, approved, and properly archived in a regulated environment.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field is required.
• 2-5 years of experience in a regulated industry (pharma, biotech, or medical device).
• Working knowledge of GMP principles, ISO 13485 and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820).
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Responsibilities

• Document Control Operations including issuance, revision, approval routing and archiving of controlled documents.
• Maintain document master lists and revision histories to reflect current approved version.
• Manage document distribution and destruction of obsolete documents.
• Coordinate training assignments for new and revised documents.

Skills

GMP principles

ISO 13485 familiarity

FDA regulatory knowledge

Microsoft Office

Problem solving

Education

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field

Tools

eQMS platforms (MasterControl, Veeva Vault, Agile)

Job description

ProMed is seeking a Quality Systems Specialist to manage the day-to-day document control within the Quality Management System, ensuring ISO 13485 and FDA 21 CFR 820/Part 11 compliance. You will drive continuous improvements in the QMS to support manufacturing operations and audit readiness.

The role involves overseeing change management, training coordination, and ensuring controlled documents are current, approved, and properly archived in a regulated environment.