Quality Manager - Medical Devices
The Role
Key Responsibilities
Post-Market Surveillance (PMS) and Vigilance
* Oversee and manage PMS and vigilance activities.
* Initiate discussions on reportability with team members.
* Ensure compliance with regulatory timelines for reportability.
* Draft and submit Manufacturer Incident Reports to health authorities.
* Lead or support Field Safety Corrective Actions (FSCA) and recall activities as needed.
* Maintain documentation in compliance with MDR and ISO 13485:2016.
* Ensure QMS compliance across the organization.
Quality Management System (QMS) Improvement
* Lead and support quality improvement projects.
* Sustain and enhance the Quality Management System.
Point of Contact for Quality Topics with Suppliers and Distributors
* Act as the primary point of contact for quality-related topics with suppliers and distributors.
* Collaborate closely with external stakeholders such as suppliers, distributors, Notified Bodies (NB), and authorities.
Internal Audits
* Conduct internal audits, write reports, and register non-conformities.
* Ensure CAPA documentation and follow-up actions are completed.
External Audits
* Support and manage logistics during external audits.
Additional Responsibilities
* Review and manage complaint documentation, ensuring timely information for manufacturer investigations.
* Register and close complaints in accordance with internal procedures.
* Organize sample shipments and continuously refine the process.
* Improve IT tools used for complaint handling.
* Collaborate with the Operations team to manage goods return and quarantine procedures.
* Conduct trend analysis for complaint data.
* Prepare reports and documentation for management reviews.
Qualifications
* Bachelor's degree in engineering, science, or a related field.
* Minimum of 5-10 years of experience in quality assurance or regulatory affairs within the medical device industry.
* Strong knowledge of MDR, ISO 13485, and quality management systems.
* Experience in handling complaints and vigilance activities is preferred.
* Proficiency in conducting internal audits and managing CAPA.
* Excellent communication and interpersonal skills.
* Detail-oriented with strong analytical and problem-solving abilities.