Quality Systems Specialist

PROMED MOLDED PRODUCTS INC•Plymouth, MN

2d•$66,870 - $92,281•Onsite

About The Position

The Quality Systems Specialist is responsible for the day-to-day administration, maintenance, and continuous improvement of document control within the Quality Management System (QMS), ensuring QMS components are accurate, current, properly revised, approved, accessible, and archived in compliance with regulatory requirements for the pharmaceutical and medical device industries. This position exercises independent quality judgment on decisions affecting ProMed's manufacturing activities. The Quality Systems Specialist supports ProMed’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

Requirements

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)

Nice To Haves

Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile) even if primary system is paper-based
Experience with ISO 13485 quality management principles
Knowledge of ALCOA+ data integrity principles
Ability to work autonomously, effectively manage time and deliver results on time
Attention to detail and commitment to data integrity and accuracy in all quality records
Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations

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 ensure all controlled documents reflect the current approved version
Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use
Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements
Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards
Manage electronic and physical document repositories
Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs)
Oversee the creation, review, approval, and distribution of controlled documents — including SOPs, policies, forms, and work instructions — in accordance with ALCOA principles
Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion
Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner
Maintain documentation files in compliance with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11
Input data to create and revise material and method masters in the ERP system
Make independent quality decisions and notify management of actions taken
Identify, propose, and implement quality process and system improvements
Investigate and resolve complex technical issues using strong problem-solving skills
Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager
Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities
Support the implementation of regulatory changes and quality system improvements as directed
Assist in preparing responses to audit observations or regulatory findings involving document or records management