Job Description

The Quality Management System (QMS) Specialist will be responsible for developing, implementing, maintaining, and improving the company’s Quality Management System (QMS). This role ensures that the QMS is compliant with ISO 13485, ISO 9001, 21 CFR 820, and 21 CFR 58. The QMS Specialist will support cross-functional teams in achieving quality objectives, ensure continuous process improvement, and maintain high standards for product quality and safety.

Key Responsibilities:

1. Document Control Management:

• Oversee the lifecycle of all QMS documentation, including creation, revision, approval, and archiving on electronic QMS.
• Manage and maintain document control processes, ensuring compliance with applicable standards such as ISO 9001, ISO 13485, and FDA regulations.
• Ensure that QMS documentation is distributed to the relevant teams and accessible as needed, ensuring proper security and access control.

2. Complaint Management – Service Labs

• Address customer complaints related to service quality, investigating issues, and collaborating with cross-functional team to provide timely solutions.
• Manage the repeat testing of samples, ensuring proper documentation and resolution of any quality concerns.

3. Cross-Functional Support

• Provide training to employees on document control processes, ensuring understanding of proper procedures for document creation, approval, and revisions.
• Act as a resource for team members regarding document control procedures and QMS documentation standards.
• Provide support to Project Management team in batch record creation, review, release, and training for special orders.
• Support Maintenance team in tracking equipment calibration and preventive maintenance logs.
• Perform quality control testing as needed.

4. Audit and Inspection Support:

• Manage QMS Process Audits to ensure adherence to ISO 13485, ISO 9001, and 21 CFR 820.
• Assist in preparing for regulatory inspections, ensuring QMS documentation is up-to-date and organized for review.
• Performs final Quality Control document review prior to product shipment.

5. Nonconformance, CAPA, and Change Control Documentation:

• Maintain and track documentation related to nonconformances, change control, corrective actions, and preventive actions (CAPAs).
• Ensure CAPA and Change Control documentation is complete and adheres to QMS requirements, supporting timely resolution and verification of actions.

6. Reporting and Documentation Metrics:

• Track key performance metrics related to QMS compliance.
• Generate reports on document control activities, highlighting key issues, trends, and areas for improvement.

Qualifications

• Education: Bachelor’s degree in business administration, Life Sciences, Engineering, or a related field. Certifications in document control, quality management, or regulatory affairs are a plus.
• Experience: 2+ years of experience in document control or quality management systems, ideally in a regulated industry (e.g., medical devices, pharmaceuticals, food, etc.).
• Skills: * In-depth knowledge of document control processes and systems. * Familiarity with quality management systems such as ISO 9001, ISO 13485, and regulatory standards (FDA, GMP). * Strong attention to detail, organizational skills, and the ability to manage multiple priorities. * Proficiency in document control software or Quality Management Systems (QMS) platforms. * Excellent written and verbal communication skills, with the ability to work collaboratively with cross-functional teams.

Desired Skills:

• Experience with electronic document management systems.
• Strong understanding of regulatory compliance and document retention requirements.
• Ability to manage projects, meet deadlines, and adapt to changing priorities.
• Knowledge of audit processes and requirements in regulated industries.

Work Environment:

• The role may involve both office and operational environments, with regular interaction with the manufacturing floor or other departments.

Additional Information

Schedule:

• Monday-Friday 3:00pm-11:30pm

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.