Junior Product Complaints Engineer

deka; Richmond (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

Millyard Advanced Medical Products in Manchester, NH, is seeking a Junior Product Complaints Engineer to review complaints related to medical device issues and perform evaluations with limited direction.

You will ensure documentation aligns with FDA/QMS requirements, participate in CAPAs, and interface with regulators and healthcare professionals.

The role emphasizes independent work, strong writing, and teamwork in a fast-paced R&D environment.

Qualifications

• 4-year biomedical engineering degree or 2-year degree with 2+ years in cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Experience in complaint handling or quality engineering is preferred; school projects and internships count.
• Knowledge of FDA quality system requirements (21 CFR 803, 820, 211) is preferred.
• Salesforce experience is a plus.

Responsibilities

• Review complaints related to potential medical device issues.
• Perform product complaint evaluations with minimal direction.
• Ensure complaint documentation meets FDA, QMS, and Good Documentation Practices.
• Identify and decide on medical device reporting to regulatory agencies.
• Interface with third party manufacturers, healthcare professionals, and regulators.
• Participate in audits and CAPA investigations related to complaints.
• Collaborate with forensic investigations to align product investigations.
• Generate reports to identify process improvements.
• Develop product training aids.
• Communicate effectively with coworkers, customers, contractors, and vendors.
• Serve as a subject matter expert on complaint handling.
• Perform other related duties as assigned.

Skills

Biomedical engineering degree

GMP/compliance knowledge

FDA regulatory knowledge

Salesforce

Time management

Technical writing

Independent contributor

Team collaboration

Education

4-year biomedical engineering degree

2-year biomedical engineering degree + 2+ years relevant experience

Tools

Salesforce

Job description

DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Junior 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:

• 4-year biomedical engineering degree; OR 2-year biomedical engineering degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.
• Experience in complaint handling or quality engineering preferred (school projects and internships considered)
• 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 & 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.