CAPA Specialist

California, San Francisco

Posted: 04/15/2019 Industry: Engineering Job Number: 12952

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a CAPA Specialist for a 6 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Position Description (Principle Duties and Responsibilities)

Reviews and thoroughly understands NC/CAPA procedures and applicable regulations.
Oversees the conduct of NC/CAPA investigations to ensure investigations are completed in a timely manner.
Reviews and approves NC/CAPA documents for accuracy, completeness, and technical validity.
Prepares, plans, and conducts CAPA Review Board (CRB) meetings.
Participates in Non-Conformance Monitoring Board Meeting (NCMB).
Performs risk assessment on product non conformances.
Approves and submits risk assessments and resource assessments to CRB
Performs other duties as assigned by manager.
Responsible for developing and implementing professional training.
Has the independence and authority to perform required tasks to ensure all provisions of the quality system are met.
Commitment to excellence and high standards.
Excellent written and oral communication skills.
Strong organizational, problem-solving, and analytical skills.
Ability to manage priorities and workflow.
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Acute attention to detail.
Proficient on Microsoft Office (Word, Excel, Access and PowerPoint).
Proven ability to handle multiple projects and meet deadlines.
Good judgment with the ability to make timely and sound decisions.
Competent understanding ISO 9001, ISO 13485 and GMP regulations.
Creative, flexible, and innovative team player.
Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
Basic PC skills.
Bachelor s degree in engineering or life sciences.
2-4 years related experience preferred

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