Product Complaints Engineer

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. **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 Technologies:** 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](https://www.dekaresearch.com/) - Contract Manufac…