This quality engineer position applies engineering and statistical principles to evaluate product performance to improve the safety, reliability and maintainability of products and systems. This position investigates complaints; establishes and maintains trending triggers and standards for product performance and develops necessary plans to ensure product reliability and overall product goals are met. Provide guidance/support in areas of process engineering, product quality assurance and quality engineering to drive continuous process and product improvements based on sound engineering principles and field product performance. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Perform timely completion of complaint investigations, Corrective Action and Preventive Action (CAPA) decisions, and Device History (DHR) reviews, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
- Maintain, monitor, and report trend analysis information on commercial product. Initiate discussions with management when new failure mode trends are identified, providing performance data as it becomes available.
- Maintain product risk management file for commercial product, including design and process risk analyses, post market surveillance reports, risk management plans and reports.
- Support returned product analysis and failure investigation activities for commercial product.
- Prepare response for regulatory inquiries, as assigned.
- Perform other related duties and responsibilities, as assigned.
- Bachelor of Science in engineering
- 5+ years’ experience in Engineering or Quality in the medical device industry.
- Experience with complaint handling in compliance with the MDD, FDA MDR, and ISO 13485; EU MDR transition experience preferred.
- Advanced computer skills, including statistical/data analysis and protocol/report writing.
- Strong communication skills, both verbal and written.
- Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
- Light work, exerting up to 20 lbs. of force or less.
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
- Requires typing, talking and hearing.
- Travel <10%
To apply, please submit your cover letter and resume as one document below.
|Position Reports to:||VP Regulatory, Quality|