Product Complaints Engineer - Team Lead

DEKA Research & Development Corp.; Manchester (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

DEKA Research & Development Corp. seeks a Product Complaints Engineer - Team Lead to join Millyard Advanced Medical Products in Manchester, NH.

The role focuses on leading complaint investigations, maintaining regulatory documentation, and driving improvements in the QMS within a fast-paced medical device environment. The position reports to the Product Complaints Manager and involves collaboration with cross-functional teams to ensure timely, accurate reporting and CAPA handling.

Qualifications

• 4-year engineering degree in biomedical engineering with 3+ years in a cGMP environment for complaint handling or reporting.
• Or a 2-year degree with 5+ years of relevant cGMP experience.
• Knowledge of FDA QMS requirements (21 CFR 803, 820, 211) preferred.
• Salesforce experience preferred.
• Strong documentation, time management, and cross-functional collaboration.

Responsibilities

• Lead a small team of Product Complaints Engineers focused on one or more medical devices.
• Review complaints related to potential device-related issues.
• Perform product complaint evaluations with minimal direction.
• Ensure complaint documentation complies with FDA regulations and QMS.
• Interface with manufacturers, healthcare professionals, and regulators.
• Participate in audits and CAPA investigations related to complaints.
• Work with forensic investigations to align product findings.
• Author procedures and work instructions and establish training programs.
• Contribute independently and with team members; maintain professional communication.

Skills

Time management

Team collaboration

Problem solving

Communication skills

Independent work

Attention to detail

Education

Bachelors in Biomedical Engineering

Associate degree with 5+ years experience in cGMP

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.