Global Principal CAPA Engineer

At CooperSurgical, a leading fertility and women's healthcare company, we are dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. We deliver innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

We are currently seeking a Global Principal CAPA Engineer to join our team. As a key member of our quality assurance department, you will be responsible for evaluating CAPA initiation, investigation, action execution, effectiveness, and robust CAPA documentation.

Key responsibilities include:

• Evaluating CAPA initiation, investigation, action execution, effectiveness, and robust CAPA documentation.
• Supporting CAPAs across different sites of CooperSurgical to ensure they are on track.
• Developing and executing global CAPA procedures and policies.
• Driving rigor in CAPA phases by coaching CAPA owners on the CAPA process.
• Ensuring CAPA practices comply with legal and ethical standards of the organization.
• Developing, analyzing, and reporting on CAPA metrics and maintaining the CAPA log.
• Ensuring CAPA records are robust, timely, and compliant with the CAPA process.
• Providing training on successful CAPA root cause investigation, corrective action execution, and effectiveness checks.
• Maintaining CAPA guidance material by keeping the content up to date for training and on-boarding.
• Leading CAPA reviews and coaching CAPA owners on planning, implementing, and documenting CAPA records.
• Completing other CAPA and quality-related functions and projects as assigned.