Manager, Customer Complaint Compliance

This Client develops and produces blood recovery systems that automate the collection of blood products from donors. These systems permit blood banks to collect and process whole blood, taking only the components, such as plasma or red blood cells, that they might need.  The Client also makes systems that collect and re-infuse a patient’s own blood during surgery.  They also sell information management software and provides consulting service  to blood banks and hospitals.  They are seeking the best people to join their dynamic family of committed employees.  They have identified the need to add a MANAGER, CUSTOMER COMPLAINT COMPLIANCE  who will be responsible for ensuring that customer complaints are properly investigated and trended, that effective corrective and preventive actions (CAPA) are taken and reported.

JOB DESCRIPTION

The MANAGER, CUSTOMER COMPLAINT COMPLIANCE will:

• Manage the Customer Complaint Compliance Program and ensures that it complies with FDA 21 CRF 820, MDD 93/42/EEC, CMDR and ISO 13485


• Ensure that complaints are properly documented, investigated and responded to.


• Analyze complaint trends and ensure that appropriate corrective and preventive actions are taken


• Determine need for and notification of MDR/ADE (vigilance) events


• Provide liaison between Quality Systems, Manufacturing and R&D to provide analysis for global quality issues


• Support the internal audit programs and Quality Systems controls program


• Provide management reports on the effectiveness of the program, including CAPA, complaint reporting and handling, and product launch surveillance processes.

                                                                 QUALIFICATIONS

The MANAGER, CUSTOMER COMPLAINT COMPLIANCE  will have:

• BS in Life Science or Engineering


• 5+ years experience in Quality Assurance and Compliance for the design and production of medical devices


• Experience working in a cGMP manufacturing facility


• Working knowledge of MDD 93/42/EEC, ISO 13485,  21 CFR 820, CMDR


• Excellent written and oral communications skills


• Demonstrated management skills


• Proficiency in MS Office applications


• Ability to travel 10-15% domestically and to Asia


• Residency in Greater Boston Area