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Sr Complaint Manager
Job Summary and Primary Duties:
- Ensure that systematic complaints are properly detected and assigned to the Höchberg Complaint Mangers, or to associated or affiliated Complaint Managers when appropriate, as described in the Vyaire Quality Management System (QMS) documentation.
- Regularly report, at a minimum during Management Reviews, on the performance of the Höchberg complaints system to local management for review and provide details and or recommendations for any needs for improvement.
- Support and follow up with Complaint Mangers as described in Vyaire QMS documentation with failure investigation and problem solving.
- Ensuring the promotion and awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Establish and maintain an effective Complaints Handling System in accordance with Vyaire Medical’s Requirements and Definitions.
- Ensure compliance and product quality to best serve our patients.
- The Sr. Complaint Manger shall collect and evaluate existing complaints concerning risks connected to Höchberg Medical Devices and shall forward Reportable Events to the PRRC, or appropriate responsible person in Vyaire, for fulfilment of reporting obligations to Competent Authorities.
- Managing the complaint process and ensuring complaint records are complete and investigations conducted, where necessary.
- Coordinate Complaint Managers, and when appropriate Medical Device Consultants, to ensure on time complaints closure.
- CAPA Champion: Ensure corrective and preventive actions are initiated if necessary to support continuous improvement, product quality and quality system compliance.
- Provide training and education at all levels of the organization and promotes understanding and awareness of complaints handling requirements.
- Escalate compliance and/or product quality issues to the Director of Quality and/or other senior leadership as needed.
- Support, and where appropriate manage, Höchberg failure analysis laboratory (FA-Lab) and personnel. Supports cross-functional site complaint investigations, as needed.
- Education: Bachelor’s degree in a technical field required. Graduate degree preferred. DGQ-Process Manager Certificate, DGQ-Quality Representative Certificate, DGQ-Quality Manager Certificate are all advantageous to have.
- Experience: REGULATION (EU) 2017/745 (MDR), COUNCIL DIRECTIVE 93/42/EEC (MDD) as applicable, FDA regulations & guidance (Title 21 Code of Federal Regulations Part 820 – Quality System Regulation), international standards (e.g., ISO 13485, MDSAP jurisdictions), Production, Research & Development, Quality Planning methods, Laws and Directives, Guidelines, Measuring- and Test techniques, Risk-Management, Continuous improvement techniques, problem solving techniques, data analysis, 5+ years of experience required, strong communication skills required.
- Knowledge: REGULATION (EU) 2017/745 (MDR) specifically chapter VII, COUNCIL DIRECTIVE 93/42/EEC (MDD), FDA regulations & guidance (Title 21 Code of Federal Regulations Part 820 – Quality System Regulation, Part 803, Part 806), Business English, EDP-System, GMP, GCP, MS Office applications, and global standards (e.g., ISO 13485, ISO 9001, etc)
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