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 2019Selected Partners- Contract Designer: DEKA Research & Development
- Contract Manufacturer: Merrimack Manufacturing
