CAPA Quality Engineer

Job Responsibilities

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
• Project manage all aspects of CAPA activity which includes gaining the commitment of cross‑functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross‑functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non‑conformances.
• Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
• Independently produce and complete CAPA (Corrective and Preventive Action) records.
• Perform timely, detailed CAPA engineering tasks such as assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem‑solving.
• Understand and analyze complex problems, including software and hardware design issues.
• Demonstrate knowledge of tools and techniques required to conduct thorough root cause analysis and develop strong investigations.
• Strong understanding of global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
• Partner with the business and effectively interact with and influence employees and managers at all levels.
• Strong Project Management skills, including the ability to manage all CAPA activities, analyze data and apply statistical techniques.
• Excellent written and verbal communication skills.
• Lead CAPA engineering activities such as assessing complex investigations, implementing corrective actions, reviewing test and performance data, performing complex root cause analysis and solving complex quality problems.

• Bachelor’s engineering degree with >5 years of related experience, or a Master’s degree with >3 years of related experience.

• These critical resources are being added to support the injunction lift and to get the CAPA program back to a healthy state.

Paid sick leave, Medical/Dental (optional), 401(k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.

ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.