Kaygen
KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.
The
Sr. Quality engineer with Complaint Specialist -
is responsible for post-market surveillance and complaint handling for medical devices. This role involves conducting product failure investigations in a controlled lab environment, managing complaint records, writing investigation reports, and ensuring compliance with regulatory standards including FDA and Health Canada. The ideal candidate will have strong analytical and technical skills, experience with medical devices, and the ability to communicate effectively with internal and external stakeholders.
Key Responsibilities
Conduct complaint investigations and perform root cause analysis on returned medical devices. Write clear, concise, and scientifically sound
Failure Investigation Reports (FIRs) . Handle and assess product returns, including working with
hazardous materials
in a controlled laboratory environment. Ensure
timely and accurate documentation
of complaint records in accordance with
Good Documentation Practices (GDP) . Support
regulatory reporting
activities, ensuring compliance with
FDA (21 CFR 820)
and
Health Canada
timelines and requirements. Coordinate with internal teams (R&D, Quality, Clinical, Regulatory) to ensure thorough complaint resolution and risk mitigation. Collaborate with
supervisors, managers, and nurses (RNs)
to assess clinical severity and context of complaints. Assist with internal and external audits and inspections, including those from
regulatory bodies . Respond to inquiries from regulatory agencies, customers, or business partners regarding complaint cases. Maintain complaint data to support
trend analysis and continuous improvement
initiatives. Qualifications
Education:
Bachelor's degree in a related technical or scientific field (e.g., Engineering, Biomedical, Life Sciences) required or preferred. Experience:
3-5 years of experience in the
medical device industry , preferably in
complaint handling, quality, or regulatory roles . 2+ years of experience in
complaint investigation or post-market surveillance
is highly desirable. Prior experience in a
regulated environment (FDA, ISO 13485, MDR)
required. Knowledge of
electronics
and mechanical systems is a plus. At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.
Benefits :
Free Healthcare Insurance Vision and Dental Insurance 401(k) Retirement Plan Free Life Insurance Sick Time Off Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:
Certifications
Mentorship Program Referrals Family and Wellness benefits Continuous Growth and Career Development
The
Sr. Quality engineer with Complaint Specialist -
is responsible for post-market surveillance and complaint handling for medical devices. This role involves conducting product failure investigations in a controlled lab environment, managing complaint records, writing investigation reports, and ensuring compliance with regulatory standards including FDA and Health Canada. The ideal candidate will have strong analytical and technical skills, experience with medical devices, and the ability to communicate effectively with internal and external stakeholders.
Key Responsibilities
Conduct complaint investigations and perform root cause analysis on returned medical devices. Write clear, concise, and scientifically sound
Failure Investigation Reports (FIRs) . Handle and assess product returns, including working with
hazardous materials
in a controlled laboratory environment. Ensure
timely and accurate documentation
of complaint records in accordance with
Good Documentation Practices (GDP) . Support
regulatory reporting
activities, ensuring compliance with
FDA (21 CFR 820)
and
Health Canada
timelines and requirements. Coordinate with internal teams (R&D, Quality, Clinical, Regulatory) to ensure thorough complaint resolution and risk mitigation. Collaborate with
supervisors, managers, and nurses (RNs)
to assess clinical severity and context of complaints. Assist with internal and external audits and inspections, including those from
regulatory bodies . Respond to inquiries from regulatory agencies, customers, or business partners regarding complaint cases. Maintain complaint data to support
trend analysis and continuous improvement
initiatives. Qualifications
Education:
Bachelor's degree in a related technical or scientific field (e.g., Engineering, Biomedical, Life Sciences) required or preferred. Experience:
3-5 years of experience in the
medical device industry , preferably in
complaint handling, quality, or regulatory roles . 2+ years of experience in
complaint investigation or post-market surveillance
is highly desirable. Prior experience in a
regulated environment (FDA, ISO 13485, MDR)
required. Knowledge of
electronics
and mechanical systems is a plus. At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.
Benefits :
Free Healthcare Insurance Vision and Dental Insurance 401(k) Retirement Plan Free Life Insurance Sick Time Off Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:
Certifications
Mentorship Program Referrals Family and Wellness benefits Continuous Growth and Career Development