Product Complaints Engineer

DEKA Research & Development•Manchester, NH

2d•Onsite

About The Position

DEKA R&D, on behalf of Millyard Advanced Technologies, is looking for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment. The position reports to the Product Complaints Manager. This is a high visibility role with a significant direct impact in the Quality Management System.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline required.
Minimum of 3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment, with direct responsibility for complaint investigations, product quality investigations, product analysis, and complaint closure activities.
Demonstrated experience conducting complaint investigations, determining root cause, documenting investigation results, and independently driving records to closure in compliance with established timelines.
Working knowledge of FDA Quality System Regulations, Medical Device Reporting requirements, and applicable standards, including 21 CFR Parts 803 and 820.
Strong technical troubleshooting, analytical, and problem-solving skills with the ability to assess complex product performance issues and identify potential failure modes.
Exceptional time management skills with the ability to manage a high-volume complaint workload while meeting regulatory and internal closure targets.
Excellent technical writing skills with demonstrated ability to prepare clear, concise, and compliant investigation reports.
Strong written and verbal communication skills with the ability to effectively interact with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams.
Highly organized, detail-oriented, and self-motivated with the ability to work independently and make sound decisions based on available evidence.
Ability to thrive in a fast-paced, changing environment while maintaining compliance with regulations, procedures, and quality system requirements.

Nice To Haves

experience with ISO 13485 is preferred.
Experience evaluating product complaints for reportability and supporting regulatory submissions is preferred.
Experience using electronic quality management systems (eQMS), complaint handling systems, and platforms such as Salesforce is preferred.

Responsibilities

Responsible for reviewing complaints related to potential medical device issues.
Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge.
Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / 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 as they relate to complaint handling.
Work with the forensic investigation team to align product investigations related to complaints.
Generate reports to identify areas of process improvement.
Develop product training aids.
Contribute independently while also collaborating with other team members and departments needing product complaint information.
Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
Serve as a subject matter expert on complaint handling.
Perform other related duties as assigned under management supervision.