A Senior CAPA Engineer is needed for a leader in electronics, healthcare, and lighting in the Pittsburg, PA area. This job is responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.
location: Pittsburgh, Pennsylvania
job type: Contract
salary: $40.00 - 63.30 per hour
work hours: 8am to 5pm
- 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.
To succeed in this role, you should have the following skills and experience:
- Bachelor's degree plus a minimum of 5 years, or a Master's degree plus a minimum of 3 years of related experience, in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5
- Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA's 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
- Experienced Engineer with proven success within teams and delivering on organizational objectives
- Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
- Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
- strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
- strong IT Skills
- Experience level: Experienced
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.