Tarrytown, United States
over 1 year ago
This is a contractor position for a Quality Engineer with strong corrective and preventive action (CAPA) process experience for post-market medical devices. This role is expected to provide leadership and technical support for CAPAs or is a key contributor to cross functional process improvement and problem solving teams. Key responsibilities include:
- Ensures compliance to regulatory requirements per CFR 820, ISO 23485, CDMR and other applicable regulations, company procedures for CAPA systems.
- Supports Quality management, which includes ensuring that CAPAs are issued as required, properly investigated, documented, and completed on time.
- Communicates obstacles, provides solutions and leads implementation of new opportunities for improvements to work processes, production, QA review and other areas as identified.
- Trains assigned individuals in root cause analysis tools to ensure correct root cause identification, appropriate action plan identification and effectiveness verification are achieved.
- Manages quality metrics, leads corrective action review board, and develops meeting outcomes to ensure continual improvement of the CAPA process.
Required Knowledge/Skills, Education, and Experience
- BS Engineering, Science or related field is required.
- 5+ year medical device or pharmaceutical industry experience.
- Must have experience with 21 CFR 820.
- Ability to analyze and solve complex problems as well as the ability to communicate effectively across departments is crucial in this role.
- Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
Preferred Knowledge/Skills, Education, and Experience
- CQE or CQA is desirable.
- Previous experience supervising technicians and conducting and participating in FDA / customer / corporate audits is preferred.
- Ability to use MS Office products along with statistical software proficiency is preferred.
- Proficiency in statistical analysis.