CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women’s healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women’s health care clinicians. More information can be found at www.coopersurgical.com .

In the role of Global Principal CAPA Engineer you will have responsibility for leading the Global Corrective Action and Preventive Action (CAPA) Program at CooperSurgical. You will have the opportunity to apply your knowledge and experience to ensure compliance to the quality and regulatory requirements for CAPA. You will work closely with CAPA Owners in different functional areas to ensure effective execution of the CAPA Program.

• Bachelor’s Degree in biomedical engineering or technical discipline with minimum of 6 years of experience in Medical Device Industry OR Master’s Degree with 5 years of experience in Medical Device Industry.
• Minimum of 5 years of experience working with CAPAs in the medical device industry.
• Project Management Certifications are a plus such as PMP
• Experience managing projects at a Global Level in a regulated environment.
• Experience with 21 CFR 820, ISO 13485, EU MDR
• Six Sigma Green Belt or above
• Strong decision-making skills, ability to influence and collaborate with cross-functional teams

• Strong technical writing skillsAbility to provide critically review and feedback on quality record

• CooperSurgical does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law. Company policy also prohibits harassment of employees or applicants based on these characteristics.

LI-AP1

• Evaluation of CAPA Initiation, Investigation, Action Execution, Effectiveness and robust CAPA documentation
• Support the CAPAs across the different sites of CooperSurgical to ensure they are on track
• Developing and executing the Global CAPA Procedures and Policies
• Driving rigor in CAPA Phases by coaching CAPA owners on the CAPA Process o Ensuring that CAPA practices comply with the legal and ethical standards of the organization
• Developing, analyzing, and reporting on CAPA metrics and keeping the CAPA log up to date
• Ensuring CAPA records are robust, timely and compliant with the CAPA process o Provide training on successful CAPA root cause investigation, corrective action execution and effectiveness checks
• Maintain the CAPA guidance material by keeping the content up to date for training and on-boarding
• Lead CAPA reviews and coach CAPA owners on planning, implementing, and documenting the CAPA records
• Complete other CAPA and quality related functions and projects as assigned

• Bachelor’s Degree in biomedical engineering or technical discipline with minimum of 6 years of experience in Medical Device Industry OR Master’s Degree with 5 years of experience in Medical Device Industry.
• Minimum of 5 years of experience working with CAPAs in the medical device industry.
• Project Management Certifications are a plus such as PMP
• Experience managing projects at a Global Level in a regulated environment.
• Experience with 21 CFR 820, ISO 13485, EU MDR
• Six Sigma Green Belt or above
• Strong decision-making skills, ability to influence and collaborate with cross-functional teams
• Strong technical writing skillsAbility to provide critically review and feedback on quality recor