Quality Engineer

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 Quality Engineer will be tasked with providing support for the documentation, technical evaluations and investigational activities necessary for timely complaint processing and closure, in line with company procedures and regulatory standards. This position involves collaborating with various departments to ensure a thorough understanding and investigation of relevant issues. This is a unique opportunity to join a growing group to grow into a forward-thinking organization.

Duties and Responsibilities include:

• Establish and maintain comprehensive complaint files and databases, adhering to both U.S. and international regulatory standards.
• Process complaints and incident reports (MDR and Vigilance), ensuring they are thoroughly documented, reviewed, evaluated, investigated, reported if necessary, and closed promptly.
• Examine and assess all feedback to determine if it qualifies as a customer complaint.
• Collaborate with Customer Service, Engineering, Quality, and investigation teams to gather root cause determinations and accurately document the closure of complaints.
• 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.
• Working knowledge of 21 CFR 820, 21 CFR 803, ISO-13485, ISO-14971, MEDDEV Vigilance Guidance, (EU) 2017/745
• Proficiency in computer applications, including Outlook, Word, Excel, andPowerPoint.
• 1+ years of experience in a medical device complaint handling documentation & processing preferred.
• Must demonstrate highly developed communication skills including well developed writing skills and verbal and interpersonal skills
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function in a minimally supervised environment with exceptional attention to detail required
• Extended work hours may be necessary to meet business demands