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CAPA Consultant

Company: Eliassen Group
Location: Somerville
Posted on: June 19, 2022

Job Description:

We have an excellent job opportunity available as a CAPA Consultant! If you are looking for a job that impacts others, then this is the job for you!

Our role is expected to last 6 months

Our client is looking for this consultant to:
Drive CAPA activities from end to end
Project manage all CAPA activities, ensure quality of CAPA records
Facilitate CAPA investigations from issue identification through implementation
Represent CAPAs during audits and CAPA review board meetings
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

Experience:
Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions
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
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

Job ID: 367857 About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

Keywords: Eliassen Group, Somerville , CAPA Consultant, Professions , Somerville, Massachusetts

Click here to apply!

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