Sr. Quality Engineer (Complaints)

Senior Quality Engineer

Join a globally renowned innovator in medical devices who is seeking an expert senior quality engineer to join their team. Recently, the company received FDA approval for its latest device focusing on diabetes, which offers unparalleled accuracy and convenience for glucose management. Be part of a team that is creating breakthrough technology to transform the lives of patients.

The Senior Quality Engineer will be tasked with leading the documentation, oversight, and direct support of technical evaluations and investigation activities necessary for timely complaint processing and closure, in line with company procedures and regulatory standards. This position involves collaborating across various departments to ensure a thorough understanding and investigation of relevant issues

Duties and Responsibilities include, but are not limited to:

• Process complaints and incident reports (MDR and Vigilance), ensuring they are thoroughly documented, reviewed, evaluated, investigated, reported if necessary, and closed in a timely manner.
• Establish and maintain comprehensive complaint files and databases, adhering to both U.S. and international regulatory standards.
• Collaborate with Customer Service, Engineering, Quality, and investigation teams to gather root cause determinations and accurately document the closure of complaints.
• Analyze and understand failure modes and root causes of various complaints, including device malfunctions and user errors, and link them to risk IDs in the risk management files.
• Conduct monthly trending and analysis of complaints and failure modes, including calculating occurrence ratings and assigning risk ratings.
• Support internal and external audits related to customer complaint handling and documentation.
• Maintain a thorough understanding of the data required for technical and AE complaints to ensure compliance with regulations and directives.

Knowledge, Skills, and Abilities:

• A Bachelor's degree in Engineering or a related scientific field is preferred.
• Familiarity with regulatory standards such as 21 CFR 820, 21 CFR 803, ISO-13485, ISO-14971, MEDDEV Vigilance Guidance, and (EU) 2017/745.
• Exceptional writing skills, capable of translating complex technical investigations into clear, concise documents understandable by non-technical reviewers.
• Proficiency in computer applications, including Outlook, Word, Excel, and PowerPoint.
• Experience in environments regulated by GMP and/or ISO is advantageous.
• 4-6+ years of experience in handling documentation and processing of medical device complaints is preferred.
• Demonstrated ability to work effectively within cross-functional teams.