capa quality engineer. + pittsburgh , pennsylvania + posted october 24, 2024 **job details** summary + $55 - $60 per hour + contract + bachelor degree + category computer and mathematical occupations + reference1070160 job details job summary: + At least a bachelor's degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment + At least 10 year's practical experience with CAPA + 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 14971Demonstrated 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 + strong reasoning and logical thinking skills + Excellent written and verbal communication skills in English location: Pittsburgh, Pennsylvania job type: Contract salary: $55 - 60 per hour work hours: 8am to 4pm education: Bachelors responsibilities: + Your responsibilities + Critically review product and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow + Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring + Support updating the business processes relating to CAPA + 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 + 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 + Support and prepare spokespersons in representing 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 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 + Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement qualifications: + Experience level: Experienced + Minimum 10 years of experience + Education: Bachelors (required) skills: + QualityEqual 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 HRsupport@randstadusa.com.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.