Job ID: 7566
Job Title: Quality Systems Specialist
Location: Greater Boston, MA
Location: MA
My client is an innovative, commercial-stage medical device company committed to empowering patients to make informed treatment decisions. By leveraging cutting-edge technology and forward-thinking innovation, they aim to transform the healthcare experience. They focus on delivering solutions that enhance patient outcomes, streamline provider workflows, and address critical needs across diverse therapeutic areas.
Position Overview: The Quality Systems Specialist ensures compliance with US FDA regulatory requirements and internal company procedures and policies. This role is a critical interface among cross-functional teams to support activities governed by 21 CFR Parts 820 (Quality System Regulation) and 21 CFR Part 803.
Responsibilities:
- Oversee document lifecycle management, including creation, revision, approval, and archival of QMS records, policies, procedures, forms, and work instructions.
- Ensure compliance with document control processes and FDA regulations.
- Serve as a subject matter expert for electronic document management systems.
- Lead updates to QMS procedures, including SOPs, ensuring alignment with current regulatory requirements.
- Identify and implement process improvements to enhance operational efficiency.
- Coordinate training activities for newly implemented and revised QMS documents.
- Develop materials and resources to facilitate training and ensure compliance.
- In conjunction with the CAPA process owner and NC owner, assist in these processes to help ensure effectiveness.
- Provide coaching and advice in CAPA and NC excellence as necessary.
- Facilitate and guide CAPA and NC teams through the CAPA and NC processes, including root cause investigations, risk assessments, solution planning, implementation, and verification of effectiveness.
- Collaborate with the Audit Process Owner to maintain accurate records in the Internal Audit Log and ensure timely completion of audit activities.
- Support the execution of internal audits and follow-up on findings.
- Monitor regulatory changes and update relevant documentation as needed.
- Assist with Quality Management Review preparations, including creating and
- maintaining metrics and reports.
- Contribute to FDA inspection readiness by supporting document requests and back-room activities.
Requirements:
- Bachelor’s degree in a related field (e.g., engineering, science, or quality management) is preferred.
- 3–5 years of experience in Quality Systems or a related role in medical devices.
- Strong knowledge of regulatory requirements, including ISO 13485, 21 CFR Part 820, and 21 CFR Part 803.
