QMS Documentation & Compliance Specialist

PROMED MOLDED PRODUCTS INC; Plymouth (MN); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account

Job summary

PROMED MOLDED PRODUCTS INC in Minnesota is seeking a Quality Systems Specialist to lead the QMS document control and compliance activities. The role requires independent judgment to ensure documents are accurate, revised, approved, and audit-ready under ISO 13485, FDA 21 CFR 820 and 21 CFR Part 11.

You will manage change requests, training records, and periodic reviews, while driving continuous improvement through ALCOA+ data integrity and effective collaboration with SMEs and QA.

Qualifications

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

• Maintain the lifecycle of controlled documents from creation to archiving.
• Ensure compliance with ISO 13485, FDA 21 CFR 820 and 21 CFR Part 11.
• Coordinate change requests, reviews, approvals, and distributions.
• Support periodic reviews, training assignments, and audit readiness.
• Identify and mitigate compliance risks within the QMS.

Skills

Attention to detail

Data integrity

Problem solving

Organization & time management

MS Office

Communication

Education

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

Tools

MasterControl

Veeva Vault

Agile

ERP system

Job description

PROMED MOLDED PRODUCTS INC in Minnesota is seeking a Quality Systems Specialist to lead the QMS document control and compliance activities. The role requires independent judgment to ensure documents are accurate, revised, approved, and audit-ready under ISO 13485, FDA 21 CFR 820 and 21 CFR Part 11.

You will manage change requests, training records, and periodic reviews, while driving continuous improvement through ALCOA+ data integrity and effective collaboration with SMEs and QA.