Our client is an International Medical Device organization that has over 70,000 employees worldwide. With over 100 years in the Healthcare Industry, our client has multiple product lines ranging from Class 1 to Class 3 medical devices. Our client specializes in data analytics, diagnostic technologies, clinical monitoring, and Imaging Systems.
Sr. CAPA Engineer
To guide and support Business Groups, Markets and enabling functions to correctly process Corrective and Preventive Actions (CAPAs). This involves being a confident and capable working partner advising on the correct execution of the CAPA process and documentation of CAPA records.
Working within a team environment of shared project goals:
• Conduct 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 providing CAPA deliverables per project timelines.
Document all phases of CAPA activity in compliance with applicable standards including 21 CFR part 820.1 00 and ISO 13485, and procedural requirements.
• Maintain CAPA records, keeping them in a state of audit readiness.
• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques.
• Analyze quality monitoring data sources and apply statistical techniques to
identify existing and potential causes of non-conformances.
• Guide cross functional teams assigned to product CAPA:. to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product.
• 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.
• Provide periodic CAPA trending data to management for review.
• Serve a.s TrackWise tool SuperUser/expert.
As a result of our client's renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with our client's Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs,Supplier Quality,Quality Management System, Quality .Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people
around the world. Location: Andover, MA
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strongtechnical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way oflife; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality oflife for the billions of people our brand touches each year.
Specific skill requirements for this role include:
Bachelor's degree with ? 5 years of related experience quality systems engineering; or a Master's degree with ? 3years of related experience quality systems engineering.
Bachelor's degree in an engineering or scientific related field.
S to I0 years related experience in the medical device industry. Demonstrated ability to effectively interact with and influence employees, and managers on all levels.
Must be goal-oriented and proactivein problem solving, coupled with creativity and a high energylevel.
Strong understanding of FDA regulations, lntematlonal laws and reguladons. Strong written and verbal communication skills.
Strong project management skills.
Must be able to function with minimal supervision.