Product Complaint Manager - Medical Devices

Biotechnology and Pharmaceutical Product Complaint Manager - Medical Devices Job Description:As a Manager I, you will be responsible for managing the Post Market Surveillance staff and all related compliance activities associated with the complaint handling program at BSC per corporate, domestic and international standards. The scope of responsibility encompasses managing the complaint processes to comply with corporate procedures and FDA regulations per CFR Part 820 and 803. Escalate and participate in resolution of potential product deficiencies and field action for all applicable BSC products. Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards. Serves as the Quality liaison between individuals and business units within or outside the organization regarding matters related to post market surveillance activities, including risk management and complaint handling processes for all applicable products. Ensures all complaints are reviewed, evaluated, and investigated to determine reportability to FDA under CFR Part 803 and Medical Device Directive. Maintain processes and procedures for ensuring compliance to corporate policies as well as external regulations and standards. Initiates and implements corrective and preventive actions when warranted according to the established procedures. Responsible for providing complaint trend information and customer feedback into the internal and external process. Interfaces with Quality Assurance Engineering and Research & Development for the Risk Management Program. Ensures risk management activities are compliant with ISO 14971 and internal BSC procedures. Interfaces with internal, domestic, and international auditors. Coordinates and participates in escalation of adverse complaint trends or product issues. Ensure appropriate training is provided to the Post Market Surveillance staff. Manages performance and professional growth and development of the staff through the BSC PADR program and per BSC HR policies. Evaluates/assesses the developmental/skill needs of staff on a continuous basis to ensure appropriate competencies exist to fulfill business needs. Recommends staffing or other necessary resources in order to achieve business goals and compliance requirements. Oversees the accuracy, completeness, and maintenance of the complaint records as it is documented in Global Complaint Management Database.Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area supported. Ensure employees are trained to do their work and their training is documented.Minimum education: B.S. in a scientific, engineering, or clinical discipline.Minimum experience: 5 to 8 years in Medical Device with equivalent of 1 – 2 years supervisory experience; working knowledge of FDA Regulations and applicable ISO Standards or equivalent combination of education and experience required to perform at this levelMinimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: None Please visit us online at www.bostonscientific.com for more information.