Product Complaints Engineer

DEKA R&D, on behalf of Millyard Advanced Medical Products, 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.

How you will make an impact:

• 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.
• Skills Needed to Be Successful 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; 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.
• 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.

About Millyard Advanced Medical Products:

• https://millyardadvanced.com/ Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.

Established 2019 Selected Partners Contract Designer:

• DEKA Research & Development Contract Manufacturer: Merrimack Manufacturing About DEKA: One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world.
• It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
• Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing.
• Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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