Product Complaints Engineer

DEKA Research & Development
Manchester
Full timeFunction: Communications, PR & CommunityExperience: 3-5 yearsEducation: bachelorsSkills: ["Technical troubleshooting","Analytical problem-solving","Technical writing","Communication","Time management"]

Review and evaluate medical device product complaints in a regulated R&D environment, ensuring compliant documentation and adherence to QMS requirements. Perform complaint investigations with minimal direction, determine root cause, and make sound reporting decisions for regulatory agencies, including FDA Medical Device Reporting. Partner with manufacturers, clinical stakeholders, and internal teams, support audits and CAPA investigations, and generate reports and training aids to drive process improvement.

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DEKA Research & Development
DEKA Research & Development
2 days ago

Product Complaints Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 9 hours agoStatus: Live
Reposted: similar role first listed 8 months ago

Job Summary

Review and evaluate medical device product complaints in a regulated R&D environment, ensuring compliant documentation and adherence to QMS requirements. Perform complaint investigations with minimal direction, determine root cause, and make sound reporting decisions for regulatory agencies, including FDA Medical Device Reporting. Partner with manufacturers, clinical stakeholders, and internal teams, support audits and CAPA investigations, and generate reports and training aids to drive process improvement.
Location: Manchester
Employment Type: Full time
Job Function: Communications, PR & Community

Key Responsibilities

  • •Review complaints related to potential medical device issues and perform complaint evaluations with minimal direction using product knowledge.
  • •Ensure complaint documentation follows Good Documentation Practices and meets QMS requirements while complying with FDA and other regulatory requirements.
  • •Identify and make sound decisions regarding medical device reporting to regulatory agencies.
  • •Interface with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies; participate in audits and CAPA investigations tied to complaint handling.
  • •Serve as a subject matter expert for complaint handling, collaborate with a forensic investigation team, and generate reports and product training aids to support process improvement.

Key Requirements

  • •Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
  • •3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment with direct responsibility for complaint investigations and closure activities.
  • •Demonstrated experience conducting complaint investigations, determining root cause, documenting results, and driving records to closure within established timelines.
  • •Working knowledge of FDA Quality System Regulations and Medical Device Reporting requirements, including 21 CFR Parts 803 and 820 (ISO 13485 preferred).
  • •Experience evaluating product complaints for reportability and supporting regulatory submissions; experience with eQMS/complaint handling systems and platforms such as Salesforce is preferred.
Experience:3-5 yearsMedical devicePharmaceuticalLife sciencesRegulated environment
Education:Bachelor's
Skills:Technical troubleshootingAnalytical problem-solvingTechnical writingCommunicationTime management
Tech Stack:21 CFR Part 80321 CFR Part 820ISO 13485EQMSSalesforce

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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