Product Complaints Engineer - Team Lead

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: Administration & Executive AssistanceExperience: 3+ yearsEducation: bachelorsSkills: ["Problem-solving","Time management","Communication","Organizational skills","Attention to detail"]

Lead a small team of Product Complaints Engineers in a medical device quality environment. Review and evaluate product complaints with minimal direction, ensuring documentation follows Good Documentation Practices and meets QMS and FDA regulatory requirements. Make decisions on medical device reporting, partner with manufacturers and healthcare professionals, support audits and CAPA investigations, and drive continuous improvement through complaint process tracking and clear technical writing.

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DEKA Research & Development
DEKA Research & Development
2 days ago

Product Complaints Engineer - Team Lead

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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

Lead a small team of Product Complaints Engineers in a medical device quality environment. Review and evaluate product complaints with minimal direction, ensuring documentation follows Good Documentation Practices and meets QMS and FDA regulatory requirements. Make decisions on medical device reporting, partner with manufacturers and healthcare professionals, support audits and CAPA investigations, and drive continuous improvement through complaint process tracking and clear technical writing.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: Administration & Executive Assistance
Seniority: Manager level

Key Responsibilities

  • •Lead a small team of Product Complaints Engineers focused on one or more medical devices.
  • •Review and evaluate complaints related to potential device-related issues, performing assessments with minimal direction.
  • •Ensure complaint documentation follows Good Documentation Practices and meets QMS requirements and FDA/other regulatory requirements.
  • •Identify and make sound decisions regarding medical device reporting to regulatory agencies; coordinate with third-party manufacturers, healthcare professionals, and internal stakeholders.
  • •Participate in audits and CAPA investigations related to complaint handling and track complaint processes to identify improvement opportunities.

Key Requirements

  • •4-year engineering degree (preferably biomedical engineering) with 3+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
  • •OR 2-year degree with 5+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
  • •Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, and 211) is preferred.
  • •Experience handling complaints and investigations in a quality management system, including audits and CAPA activities.
  • •Strong written and verbal communication, organizational skills, attention to detail, and sound technical writing.
Experience:3+ yearsMedical deviceCGMPQuality management systemRegulatory complianceMedical device reporting
Education:Bachelor's in Biomedical engineering (preferred)
Skills:Problem-solvingTime managementCommunicationOrganizational skillsAttention to detail
Tech Stack:Salesforce

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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