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Senior Quality Complaint Specialist
2 months ago
Recruiter:
Spencer Gregory Hale Senior Quality Complaint Specialist
About the role: This position offers specialized technical, reporting, and analytical support in the evaluation of product quality complaints, acting as the primary liaison.
Responsible for overseeing systems and data to ensure the prompt and proper management of all product complaints in accordance with the company's complaint handling protocols.
Ensures adherence to relevant regulations, company policies, and procedures.Your responsibilities include:
Conducting analysis of complaint data for both internal and external stakeholders. Collaborating with product analysts, engineers, and unit managers regarding complaint evaluations.
Completing Medical Device Reporting (MDR) and Medical Device Vigilance (MDV) assessments for all assigned products. Accountable for maintaining comprehensive and precise complaint records, ensuring timely resolution of complaint files. Guaranteeing that complaint records, regulatory reports, and relevant complaint handling documents comply with Good Documentation Practices (GDP). Completing mandatory training within designated timelines and maintaining accurate training records at all times. Partnering with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports for returned products.
Engaging professionally with customers to gather insights into each complaint event. Preparing and submitting regulatory reports within required timelines. Reviewing and approving assessments, reassessments, MDRs, and MDVs as necessary.What we're looking for:
Minimal requirements:
Bachelor's degree with a minimum of 3 years of experience in managing product quality complaints in the medical device sector, or 5+ years of general product quality complaint management. Strong proficiency in standard computer applications, including Microsoft Office (Excel, Word, and Outlook).
Preferred qualifications:
Exceptional written and verbal communication skills are crucial. Must be self-driven, goal-oriented, and a collaborative team player. Strong critical thinking and effective time management skills are essential. A college degree focused on Biology, Health Sciences, Biotechnology, or Engineering is preferred. Practical experience in medical device complaint management is advantageous. Requisition ID:587335. Please note that this role is classified as safety-sensitive, and candidates will be required to undergo a prohibited substance test as part of the hiring process.
The objective of the prohibited substance testing is to enhance workplace safety in compliance with applicable laws. Boston Scientific is an Equal Opportunity Employer, committed to diversity and inclusion.