Product Complaints Engineer - Team Lead

deka; Richmond (NH); On-site; USD 90,000 - 140,000; Full time

Job summary

Millyard Advanced Medical Products in Manchester, NH is seeking a Product Complaints Engineer - Team Lead to drive complaint handling for its medical devices within a dynamic QMS.

You will supervise a small team, review complaints, perform evaluations, and ensure FDA and QMS compliance while guiding investigations with cross-functional partners. This high-visibility role supports regulatory outcomes and patient safety.

Qualifications

• 4-year engineering degree, preferably biomedical, plus 3+ years in a cGMP environment or 2-year degree with 5+ years in a cGMP environment.
• Knowledge of FDA QMS requirements and MDR/medical device reporting (21 CFR 803, 820, 211) preferred.
• Experience with medical device complaint handling and reporting.
• Strong written/verbal communication and documentation skills.
• Ability to work independently and in cross-functional teams in a fast-paced environment.

Responsibilities

• Lead a small team of Product Complaints Engineers focused on one or more DEKA life-changing medical devices.
• Review complaints related to potential device-related issues and perform evaluations with minimal direction.
• Ensure complaint documentation follows Good Documentation Practices and FDA QMS requirements.
• Identify and decide on medical device reporting to regulatory agencies.
• Interface with third-party manufacturers, healthcare professionals, internal customers, and regulators.
• Participate in audits and CAPA investigations related to complaint handling.

Skills

Team leadership

Documentation skills

Regulatory awareness

Problem solving

Time management

Education

B.S. in Biomedical Engineering or related field

2-year degree with 5+ years cGMP experience

Tools

Salesforce

Job description

DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Product Complaints Engineer - Team Lead to work in a dynamic Medical Device 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:

• Will lead a small team of Product Complaints Engineers focused on one or more of DEKA’s innovative, life-changing medical devices.
• Responsible for reviewing complaints related to potential device-related 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.
• Track complaint processes to identify areas of improvement.
• Author procedures and work instructions.
• Establish and maintain a product training program.
• Contribute independently while also collaborating with other team members and departments.
• Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
• Perform other related duties as assigned under management supervision.

Skills needed to be successful:

• 4-year engineering degree, preferably in biomedical engineering, and 3+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis; OR 2-year degree and 5+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Experience with SalesForce is preferred.
• Strong motivation to see individual tasks through to completion, and to help as needed to achieve team goals.
• Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.
• Good problem-solving and proficient computer skills are required.
• Solid written/verbal communication and organizational skills, as well as attention to detail.
• Sound technical writing skills.
• Ability to work well independently and on cross-functional teams in a fast-paced, changing environment.

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.