Product Complaints Engineer

DEKA Research & Development; Manchester (NH); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical innovation firm in Manchester, NH, is seeking a Product Complaints Engineer to address product complaints and ensure compliance with regulatory standards. The ideal candidate will possess a biomedical engineering degree and have experience in a cGMP environment. Responsibilities include conducting evaluations, interfacing with regulatory agencies, and contributing to process improvement initiatives. Strong problem-solving and communication skills are essential for this dynamic role. Join a team dedicated to innovative medical device solutions.

Qualifications

• 4-year biomedical engineering degree or 2-year degree with relevant experience.
• Knowledge of FDA regulations (21 CFR 803, 820, and 211) preferred.
• Experience in a cGMP environment preferred.

Responsibilities

• Review complaints related to medical device issues.
• Perform product complaint evaluations.
• Ensure compliance with regulatory requirements in documentation.
• Make decisions regarding medical device reporting.
• Interface with manufacturers and regulatory agencies.
• Participate in audits and CAPA investigations.
• Work with forensic investigation team on complaints.
• Generate reports for process improvement.
• Develop product training aids.
• Maintain communication with team members and external partners.
• Serve as a subject matter expert on complaints handling.

Skills

Biomedical engineering degree

Knowledge of FDA requirements

SalesForce experience

Time management

Problem-solving skills

Written/verbal communication skills

Technical writing skills

Attention to detail

Education

4-year biomedical engineering degree or equivalent

Associate degree in Biomedical Engineering or related field + 2+ years cGMP experience

Tools

SalesForce

Job description

DEKA R&D has an immediate opening 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:

• 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.
• 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 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.