Medical Device Complaint Specialist
52 Discovery Irvine, CA 92618 US
Job Description
Job Title: Medical Device Complaint Specialist
Job Summary:
The Medical Device Complaint Specialist is a key member of our quality compliance team, responsible for expertly investigating customer complaints, making initial reporting decisions, and coordinating comprehensive investigations. This role ensures accurate and complete documentation of complaints, prepares necessary medical device reports, and communicates effectively with stakeholders. The Specialist plays a vital part in maintaining regulatory compliance, safeguarding patient safety, and supporting continuous product improvement.
Key Responsibilities:
- Investigate customer complaints daily by performing initial classifications and determining which cases require escalation for regulatory reporting, such as Medical Device Reports (MDRs) or Vigilance reports for international authorities.
- Ensure all potentially reportable complaints are promptly escalated to appropriate management and regulatory bodies, maintaining compliance with applicable regulations.
- Review complaint documentation for accuracy, completeness, and consistency; initiate further actions or investigations as needed.
- Collaborate with OEM, engineering, field personnel, and quality assurance teams to investigate new failure modes and product issues.
- Participate in post-market surveillance activities, including adverse event reviews and regulatory reporting for the US, Europe, and other international agencies.
- Prepare, review, and submit medical device reports in accordance with company procedures and regulatory requirements.
- Work closely with clinical staff on hazard evaluations and assessments of patient safety risks associated with complaints.
- Monitor complaint trends, escalating significant issues to management for timely resolution.
- Support internal and external audits by representing the complaint handling process.
- Provide training to internal teams on complaint management procedures and regulatory compliance requirements.
- Interface with customers and hospital risk management personnel to gather information related to complaints.
- Draft and review customer communications and responses to regulatory agencies, ensuring timeliness and accuracy.
- Address complaints requiring customer response or follow-up as part of quality and regulatory processes.
- Assist with special projects or duties related to quality compliance as assigned.
Qualifications & Experience:
Minimum Qualifications:
- 2 to 3 years of experience in the medical device industry, with a focus on complaint handling and post-market surveillance.
- Familiarity with medical device regulations including FDA requirements (21 CFR Part 820 and Part 803), MDRs, Vigilance reports, and ISO 13485 standards.
- Experience with MedWatch and regulatory reporting procedures.
- Knowledge of medical device complaint files and quality documentation.
- Strong computer skills and proficiency in MS Office.
- Effective written and verbal communication skills.
- Ability to work independently, with keen attention to detail and a focus on quality.
Preferred Qualifications:
- Clinical background or experience in healthcare environments.
- Direct experience handling complaints and adverse event reporting.
- Bachelor’s degree in Engineering, Life Sciences, Clinical fields, or related disciplines.
Education:
- High School Diploma or GED required.
- Bachelor’s degree in Science, Engineering, or Clinical disciplines preferred.
Why Join Us?
- Contribute to patient safety and product quality in a critical industry.
- Grow your expertise with professional development opportunities.
- Collaborate with a dedicated team committed to excellence.
- Be part of a company that values innovation, compliance, and continuous improvement.
If you are detail-oriented, communicative, and passionate about quality and safety in medical devices, we invite you to apply and become a vital part of our team.
Meet Your Recruiter
Nina McCann
On-Site Manager
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.