CAPA Quality Engineer

job summary:

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.

Required Competencies:

Able to understand and analyze complex problems, including software and hardware design issues. Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations. strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971. Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels. strong Project Management skills, including ability to project manage all CAPA activities. Ability to analyze data and apply statistical techniques. Excellent written and verbal communication skills.

location: Pittsburgh, Pennsylvania

job type: Contract

salary: $55 - 60 per hour

work hours: 8am to 4pm

education: Bachelors



responsibilities:

Independently produces and completes CAPA records. Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.

Education Requirements:

Bachelor's degree in an engineering or scientific related field or equivalent demonstrated strong technical competence.

Experience Requirements:

Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971. 3+ years of related experience in medical device or other regulated industry.

qualifications:

• Experience level: Experienced
• Minimum 5 years of experience
• Education: Bachelors (required)

skills:

Quality

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.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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