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Complaint Evaluation Engineer
Applied Medical Distribution - Rancho Santa Margarita, CA
posted 5 days ago
About the position
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.
Responsibilities
- Evaluate the performance of products returned by the customer.
- Perform device analysis in accordance with model-specific procedures and protocols.
- Perform root cause analysis to investigate alleged product deficiencies.
- Propose corrective/preventive actions as required.
- Compose detailed reports describing results from investigations.
- Complete evaluations in a timely and accurate manner.
- Conduct thorough investigations and analyses to identify the underlying causes of failures and identifying trends in the complaint data.
- Ensure the accuracy, clarity, and compliance of documentation, reports, and technical materials related to products and processes.
- Efficiently prioritize and organize tasks to meet deadlines, effectively managing time constraints.
Requirements
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or a similar engineering discipline.
- Minimum of one year of experience in the medical device field or other regulated industry.
- Effective problem solving and troubleshooting skills.
- Proficient computer skills, including knowledge of spreadsheets and word processing.
- Possess excellent oral and written communication skills.
- Work independently, in a team environment and cross-functionally with other departments.
- Learn quickly and be self-motivated.
- Strong multitasking and prioritization skills.
Nice-to-haves
- Experience in conducting failure investigations, reliability testing and performing failure analysis leading to root cause and corrective/preventive actions.
- Working knowledge of Food and Drug Administration (FDA) and International Organization for Standardization (ISO) regulations.
- Working knowledge of manufacturing processes and equipment.
Benefits
- Training and mentorship with ongoing learning and development courses.
- On-campus wellness activities.
- Comprehensive medical and dental and vision coverage.
- Education reimbursement program.
- 401(k) program with discretionary employer match.
- Generous vacation accrual and paid holiday schedule.
