Quality Systems Specialist

Quality Systems Specialist

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people's lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

Why This Role Matters

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.

What You'll Achieve

You'll ensure ProMed's Quality Management System remains accurate, current, and audit-ready by maintaining tight control over the lifecycle of every controlled document — from creation through revision, approval, distribution, and archiving. Your work will keep the organization compliant with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11, while driving continuous improvements that strengthen the QMS and support manufacturing operations.

How You'll Achieve It

Document Control Operations

• 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

Change & Review Management

• 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

Compliance & Regulatory Adherence

• 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

Quality Decision-Making & Continuous Improvement

• 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

Other Responsibilities

• 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

Necessary Skills:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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).

Preferred:

• 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;

Minimum Qualifications For The Role:

• 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).

Physical, Sensory, Cognitive & Neurological Demands:

• Work is performed indoors in a climate-controlled, ventilated facility with fluorescent lighting and generally minor noise levels; occasional exposure to chemical substances used for cleaning or equipment operation may occur
• Regularly required to stand, walk, sit, stoop, bend, squat, kneel, reach, and use repetitive motions; occasionally required to move quickly and navigate smooth or uneven surfaces, including tight spaces between desks and workstations
• Frequently required to grasp and manipulate objects such as pens, markers, scissors, staplers, and whiteboard tools, which may involve reaching at, below, or above shoulder height and occasional trunk or neck rotation
• May be required to exert approximately 25+ pounds of force to push or pull equipment such as computers, overhead projectors, or televisions
• Requires close vision (e.g., reading handwritten or typed material) and the ability to adjust visual focus
• Must be able to see, hear, and speak continuously to frequently in order to communicate effectively
• Must be able to manage multiple, simultaneous demands from various internal and external stakeholders
• Requires ongoing interaction and communication with employees, management, and external contacts across the organization

How Your Success Will Be Measured:

Your Key Performance Indicators:

• Document Turnaround Time — Percentage of document change requests (creation, revision, approval) processed within established SLA timeframes
• On-Time Periodic Review Completion — Percentage of controlled documents reviewed and updated by their scheduled review date, with no overdue reviews exceeding site-defined thresholds
• Audit & Inspection Readiness — Number of document control-related findings or observations identified during internal audits, external audits, or regulatory inspections
• Training Compliance Rate — Percentage of employees who complete required training on new or revised documents within the designated timeframe
• Data Integrity & Accuracy — Accuracy rate of document control records (numbering, versioning, master lists) as measured through periodic internal reviews or audits, with minimal discrepancies identified

Expected Competencies:

Competency - Explanation

Attention to Detail - Consistently ensures accuracy and completeness in document control records, quality records, and compliance documentation

Regulatory & Quality Systems Knowledge - Applies working knowledge of ISO 13485, FDA 21 CFR