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CAPA Process Analyst II

1 month ago

Gretna, United States Experis Full time

Our client, Medical device manufacturing industry is seeking a CAPA process analyst to join their team. The ideal candidate will have CAPA , Quality assurance and technical writing which will align successfully in the organization.

Job Title: CAPA Process Analyst II

Location: Gretna, LA

Pay Range: $27 -$31

Overview:
The CAPA Process Analyst II is responsible for progressing investigations and other activities through the CAPA program. This role leads cross-functional teams in using investigational tools to determine the root cause of nonconformities, ensuring CAPA plans address root causes and are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.

Main Responsibilities:

  • Lead the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities, including nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.
  • Serve as a subject matter expert on investigation and root cause analysis techniques to ensure appropriate root/potential causes and implement effective actions to reduce the occurrence/recurrence of nonconformances.
  • Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits.
  • Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
  • Produce trending metrics and reports to identify, prioritize, and manage further actions as required.
  • Provide leadership for initiating improvement activities associated with identified trends.
  • Support a work environment that ensures team effectiveness by demonstrating full cross-functional team support that complies with corporate and regulatory requirements.
  • Ensure effective written and verbal communications.
  • Prioritize workload in relation to business needs.
  • Support the attainment of organizational goals and objectives.
  • Ensure compliance with organizational procedures, regulatory requirements, and industry standards, and timely completion of CAPAs and audit findings.

Required Qualifications:

  • Bachelor’s degree in Engineering or Life Sciences
  • Experience with Corrective and Preventative Action (CAPA) processes in medical devices or laboratories
  • Excellent communication and technical writing skills

Preferred Qualifications:

  • Understanding of statistics, Failure Modes and Effects Analysis (FMEA), and ASQ Certified Quality Engineer (CQE)
  • Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) regulations, or similar regulated industry

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.