The Corporate Site CAPA Engineer (SCE) for West Chester is responsible for development and review of Corrective and Preventive Actions (CAPA) to ensure compliance requirements are being met. The Corporate SCE will also be responsible for leading / participating on CAPA Review Boards for West Chester and the monitoring of CAPA related metrics to ensure goals are being achieved. The Corporate SCE will provide technical support utilizing Black Belt Six Sigma techniques to assess the overall state of CAPA’s
Duties & Other Responsibilities:
Professional Experience & Educational Requirements :
- Lead / participate on CAPA Review Boards in West Chester.
- Able to apply statistical methodologies across various data sources to identify trends for potential CAPA inclusion.
- Ensure investigations and root cause analyses are accurate and complete by utilizing Black Belt Six Sigma techniques which will yield effective corrective and preventive actions to eliminate root causes.
- Provide weekly updates on the status of CAPA activities. Identify any potential compliance risks and escalate those risks to management.
- Track the progress of CAPA related metrics and facilitate actions for improvement.
- Facilitate Black Belt Six Sigma root cause analysis training, coaching and mentoring as needed.
- Develop training tools for the overall CAPA program.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
- Consistently meet employee compliance requirements, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
- Performs other related duties, as required.
- Experience in medical device, pharmaceutical or other regulated industries preferred.
- 3 to 5 years of CAPA experience, specifically related 21 CFR 820.100 preferred.
- Strong statistical and root cause analysis background.
- Six Sigma or Black Belt training is required.
- Strong verbal and written communication skills.
- Excellent Computer skills required. (i.e. database management, spreadsheet, word processing and presentation preparation)
- Four-year degree (Engineering preferred)
- ASQ Certification preferred
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