May 29, 2024

CooperSurgical

OTHER

CAPA Supervisor

The role of Principal CAPA Engineer will have responsibility for leading the site Corrective Action and Preventive Action (CAPA) Program at Cooper Surgical. The incumbent will have the opportunity to apply knowledge and experience to ensure compliance to the quality and regulatory requirements for CAPA. The role work closely with CAPA owners in different functional areas to ensure effective execution of the CAPA Program

Cooper Surgical is a globally provider of more than 600 products, each with a focus on improving the health of women, babies and families additionally is a Premier Provider of Medical Devices, Fertility and Genomics Solutions.

Qualifications:

University Degree in Biomedical Engineering or technical discipline with minimum of 6 years of experience in Medical Device Industry. Master’s Degree is a plus.
Minimum of 5 years of experience working with CAPAs in the medical device industry.
Project Management Certification is a plus.
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
Leadership ability to coordinate work with multiple areas, and ability to influence with cross-functional teams.
Strong technical and decision-making skills.
Ability to provide critically review and feedback on quality record.

Cooper Surgical 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.

Essential Functions:

Evaluation of CAPA Initiation, Investigation, Action Execution, Effectiveness and robust CAPA documentation.
Support the CAPAs across the different departments of Cooper Surgical 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 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. 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.
Manage NCMR process to ensure a robust process developing through organization.
Keep following, with Quality System Manager, Quality Objectives and ensure inform to organization in case of limits trends.?
Able to establish follow-up meetings on action plans to eliminate trends of out-of-bounds objectives.