Complaints Manager - Cirencester, UK
Corin, United Kingdom

Corin is seeking a Complaints Manager to ensure complaints management procedures are optimized; ensure vigilance team responds to and resolves complaints within a timely fashion whilst conforming to the correct standards and procedures. The Complaints Manager is responsible for managing the Vigilance Team.

Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.

The responsibilities of the Complaints Manager are to:

• Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools (e.g., QPulse) in accordance with ISO13485/MDR/ 21CFR820 and other regulations as required.
  
• Lead and mentor the Complaints Vigilance team of 2-5; responsible for team goal setting and performance assessments, as well as day-to-day people management
• Make initial triage assessment of complaints and assess initial risk and severity; Evaluate that information received is sufficiently detailed and request and obtain additional details where incomplete.
• Work with all product/manufacturing/research amp; development/quality teams to ensure timely, accurate and complete investigations of product complaints and timely closures
• Review reports of customer complaints, assess them for MDR / MDV reportability to FDA / Competent Authorities
• Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
• Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file
• Update current procedures/processes or create new procedures/processes
• Generate and track metrics on process timeliness and effectiveness
• Participate in continuous improvement and process re-engineering projects in support of continuous improvement initiatives.
• Generate data for Competent Authorities (FDA, TUV/BSI and other regulatory bodies).
• Post-Marketing Surveillance activities; Supply Product Quality Metrics for Brand Review meetings or PMS reviews.
• Complete, review and approve Complaint Vigilance Reports (i.e. quarterly trending, monthly, complaint records) in a timely manner
• Perform procedural reviews and updates relating to core activities to ensure ongoing compliance and improvement to the QMS, as required.
• Promote alignment between local and regional processes to drive harmonization
• Disseminate training to other Corin UK employees on Vigilance
• Provide an environment that encourages and promotes employee involvement, continuous improvement, and compliance and fosters innovation.
• Responsible for managing the Vigilance team which includes performance assessment, personnel development, establishing annual objectives, and providing day-to-day guidance for the individuals reporting into the Complaint Vigilance Manager.
• Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS amp; Good Manufacturing Practice (GMP) FDA21 CFR Part 820.
• Ensure that process and timeline requirements for Corrective amp; Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOPs) and in support of Corin’s Global Objectives for CAPA.

Requirements

The ideal Complaints Vigilance Manager will have / be;

• BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.
• A seasoned Quality leader with a extensive experience in the medical device industry, preferably in Complaints Vigilance/Post-Market Surveillance area.
• Experience with people management
• Demonstrated applied knowledge of regulatory requirements (MDR and MDV)
• Results orientated, multi-tasker, and quick learner; understands and respond to urgency
• Excellent verbal, written and interpersonal skills.
• Applied knowledge of Microsoft Office software including Excel, Word and Power Point.

Benefits

You will receive a competitive salary and annual bonus as well as;

• 25 days holiday plus bank holidays.
• Excellent pension up to 9.7% provided by Corin when you contribute 4%
• Life assurance (6x basic salary).
• Private medical insurance with BUPA for you and your family.
• Subsidised canteen and gym membership.
• Free

Job Rewards and Benefits