QMS Specialist

About the Role

Seeking a highly skilled Quality Management System Specialist responsible for ensuring the organization's Quality Management System (QMS) complies with global regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and applicable Good Manufacturing Practices (GMP). This role administers electronic Quality Management Systems (eQMS) related to CAPAs and NCs, drives corrective and preventive action (CAPA) activities, supports audits and regulatory inspections, and drives continuous improvement initiatives to ensure product quality, patient safety, and regulatory compliance. Additionally, the position drives the Health Hazard Evaluation Program to ensure timely evaluation of risk associated with products outside of the organization’s control to make timely field action decisions.

Responsibilities

• Implement and maintain the CAPA program including software solutions.
• Monitor information relative to problem statements, root cause analysis, corrections, corrective and preventive actions, tracking of timelines, and establishing CAPA files.
• Assist and interface with CAPA owners on CAPA Investigations, Action Plans, and Verification/Validation Activities to drive timely completion of CAPA activities.
• Coordinate CAPA meetings, establish meeting times, locations, agenda, and maintain meeting minutes.
• Monitor the suitability and effectiveness of the CAPA system. Identify appropriate metrics and trend CAPA metrics, presenting defined reports at specified intervals to CAPA Committee and Management Review.
• Maintain and revise applicable quality systems interfacing with CAPA.
• Serve as a resident expert in CAPA regulatory/compliance and coach/mentor employees. Coordinate training for users of the CAPA system and develop assorted training materials. Conduct training on root cause investigation and problem-solving techniques.
• Serve as the resident expert for the Health Hazard Evaluation (HHE) program and train team members on the process that aligns with regulatory requirements.
• Lead and maintain the HHE and Field Action programs.
• Communicate with appropriate regulatory agencies on field action activities and monitor progress until field action closure.
• Support internal audit programs, document control, post-market activities, regulatory inspections, and notified body audits.
• Participate in audit response activities, including preparation of corrective action plans and closure of audit findings.
• Monitor regulatory changes and assess their impact on quality systems and procedures.

Requirements

• Bachelor’s degree in a technical discipline or an alternative Bachelor’s degree program with certification in a Quality discipline (e.g., CQE, CQA, etc.).
• 3+ years of experience or equivalent combination of education and experience in the medical device or pharmaceutical field.
• Medical Device regulations experience preferred.
• Familiarity with aspects and elements of quality systems, including CAPA, management responsibility, product realization, and measurement, analysis, and improvement processes.
• Knowledge of modern quality control/assurance techniques such as corrective/preventive action plans and root cause analysis.
• Detail-oriented with excellent time management and organization skills.
• Familiarity with Microsoft Applications such as PowerPoint and Excel.
• Reliable and capable of working with minimal supervision to manage assigned tasks and follow-up activities.
• Innovative with the ability to make sound suggestions for improvement.
• Strong oral and written communication skills for interactions with internal and external customers.
• Highly compliance-oriented to firmly adhere to principles of regulation and standards.

Schedule

Occasional travel up to 10%.