QMS Document Control Specialist

Socket.dev; Plymouth (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

ProMed is seeking a Quality Systems Specialist to manage the day-to-day document control within our Quality Management System, ensuring accuracy, revision control, and audit readiness in line with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11.

The role requires a life sciences or engineering background, 2–5 years in a regulated setting, and proficiency with eQMS tools and Microsoft Office. You will participate in continuous improvement and maintain compliance across manufacturing operations.

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

• Administer the day-to-day operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records).
• Maintain document master lists and revision histories to reflect current approved versions.
• Manage electronic and physical document repositories and ensure templates are current and compliant.

Skills

Attention to detail

Independent judgment

Problem-solving

Effective communication

Education

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

Tools

eQMS platforms (MasterControl, Veeva Vault, Agile)

Microsoft Office Suite

Job description

ProMed is seeking a Quality Systems Specialist to manage the day-to-day document control within our Quality Management System, ensuring accuracy, revision control, and audit readiness in line with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11.

The role requires a life sciences or engineering background, 2–5 years in a regulated setting, and proficiency with eQMS tools and Microsoft Office. You will participate in continuous improvement and maintain compliance across manufacturing operations.