Junior Product Complaints Engineer

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: Communications, PR & CommunityExperience: 2+ yearsEducation: bachelorsSkills: ["Problem-solving","Time management","Organizational skills","Communication","Technical writing","Attention to detail","Cross-functional collaboration"]

Review and evaluate medical device complaints with minimal direction, ensuring complaint documentation follows Good Documentation Practices and meets QMS requirements. Make sound decisions on medical device reporting to regulatory agencies, including FDA requirements. Collaborate cross-functionally with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies. Support audits and CAPA investigations, align with forensic investigation work, and create reports and training materials to drive process improvement.

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DEKA Research & Development
DEKA Research & Development
5 days ago

Junior Product Complaints Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 21 hours agoStatus: Live
Reposted: similar role first listed 1 month ago

Job Summary

Review and evaluate medical device complaints with minimal direction, ensuring complaint documentation follows Good Documentation Practices and meets QMS requirements. Make sound decisions on medical device reporting to regulatory agencies, including FDA requirements. Collaborate cross-functionally with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies. Support audits and CAPA investigations, align with forensic investigation work, and create reports and training materials to drive process improvement.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: Communications, PR & Community
Seniority: Entry level

Key Responsibilities

  • •Review complaints related to potential medical device issues and perform complaint evaluations with minimal direction.
  • •Ensure complaint documentation follows Good Documentation Practices, QMS requirements, and complies with FDA and other regulatory requirements.
  • •Identify and make decisions regarding medical device reporting to regulatory agencies.
  • •Interface with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies; maintain cooperative communication.
  • •Participate in audits and CAPA investigations related to complaint handling; support forensic investigations and generate process-improvement reports and training aids.

Key Requirements

  • •4-year biomedical engineering degree, or 2-year biomedical engineering degree plus 2+ years relevant experience in a cGMP environment supporting complaint handling, 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 and Medical Device Reporting regulations (21 CFR 803, 820, 211) is preferred.
  • •Experience with Salesforce is preferred.
  • •Strong technical writing, computer skills, attention to detail, and the ability to prioritize multiple projects while ensuring compliance with regulations and SOPs.
Experience:2+ yearsMedical deviceCGMPQuality systemsComplaint handlingRegulatoryMedical device reporting
Education:Bachelor's in Biomedical engineering
Skills:Problem-solvingTime managementOrganizational skillsCommunicationTechnical writingAttention to detailCross-functional collaboration
Tech Stack:SalesforceQMSCAPAFDA 21 CFR 803FDA 21 CFR 820FDA 21 CFR 211

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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