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Product Complaints Engineer

Product Complaints Engineer

DEKA Research & DevelopmentManchester, NH, US
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Job Description

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 engineering degree, preferably in biomedical engineering; OR 2-year 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.

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    Product Engineer • Manchester, NH, US