Job Summary
This role is responsible for conducting thorough investigations into medical device complaints, ensuring timely and accurate reporting in accordance with regulatory requirements and company standards. The ideal candidate will possess strong analytical skills, a deep understanding of medical device technology, and a commitment to quality and compliance.
Key Responsibilities
- Conduct in-depth investigations of medical device complaints, including failure analysis, root cause analysis, and risk assessment.
- Document and track complaint investigations, ensuring adherence to regulatory requirements and company quality system procedures.
- Collaborate with cross-functional teams to identify and implement corrective actions and preventive measures to address root causes of complaints.
- Analyze complaint data to identify trends and patterns, and recommend improvements to product design, manufacturing processes, or quality systems.
- Stay updated on relevant regulatory requirements and industry best practices.
- Perform other duties as assigned.
Qualifications
- Bachelor's degree in engineering, science, or a related field.
- Minimum of 5 years of experience in the medical device industry, with at least 2 years in a complaint investigation role.
- Strong analytical and problem-solving skills.
- Knowledge of regulatory requirements such as GMP, ISO, and FDA regulations.
- Proficiency in statistical analysis and data management tools.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
- Experience with complaint handling software (e.g., Sparta TrackWise Digital, Salesforce) is preferred.
Preferred Qualifications
- Advanced degree or certifications in quality engineering (e.g., ASQ, CQE, Six-Sigma).
- Experience with specific medical device technologies or product lines.
- Familiarity with laboratory equipment and testing methodologies.
