Product Complaints Engineer - Team Lead

DEKA Research & Development•Manchester, NH

About The Position

DEKA R&D, on behalf of Millyard Advanced Medical Products, is seeking a Product Complaints Engineer - Team Lead for a dynamic medical device environment. This high-visibility role has a significant direct impact on the Quality Management System and reports to the Product Complaints Manager. The role leads a small team of Product Complaints Engineers focused on one or more medical devices, and performs complaint evaluations, supports regulatory reporting decisions, and helps maintain and improve complaint-handling processes.

Requirements

A four-year engineering degree, preferably in biomedical engineering, and at least 3 years of relevant experience in a cGMP environment supporting complaint-handling investigations, medical device reporting, or product analysis; alternatively, a two-year degree and at least 5 years of such relevant experience.
Strong motivation to complete individual tasks and help achieve team goals.
Exceptional time-management skills and ability to prioritize multiple projects while ensuring compliance with regulations and standard operating procedures.
Good problem-solving and proficient computer skills.
Solid written and verbal communication and organizational skills, with attention to detail.
Sound technical-writing skills.
Ability to work independently and on cross-functional teams in a fast-paced, changing environment.

Nice To Haves

Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, and 211).
Experience with SalesForce.

Responsibilities

Lead a small team of Product Complaints Engineers focused on one or more medical devices.
Review complaints related to potential device-related issues.
Perform product complaint evaluations with minimal direction, using experience and product knowledge.
Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA and other regulatory requirements.
Identify and make sound decisions regarding medical device reporting to regulatory agencies.
Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.
Participate in audits and CAPA investigations related to complaint handling.
Work with the forensic investigation team to align product investigations related to complaints.
Track complaint processes to identify areas for improvement.
Author procedures and work instructions.
Establish and maintain a product training program.
Contribute independently and collaborate with team members and other departments.
Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
Perform other related duties as assigned under management supervision.