CooperCompanies
Description
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. As a division of Cooper Companies, we are driven by a unified purpose to enable patients to experience life’s beautiful moments. Guided by our shared values—dedicated, innovative, friendly, partners, and do the right thing—our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to women’s and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at .
Responsibilities
Lead initiatives to maintain and improve the Quality Management System (QMS) in compliance with FDA Quality Systems Regulations (QSR) ISO 13485 EU MDR and other applicable regulations.
Develop implement and maintain quality processes, procedures and metrics to ensure consistent product quality and regulatory compliance.
Support internal and external audits including but not limited to FDA ISO and notified body inspections.
Lead risk assessments (FMEA, Fault Tree Analysis) for new and existing processes.
Drive root cause analysis and corrective / preventive actions (CAPA) for process‑related nonconformances and complaints.
Monitor and report on quality metrics and trends to identify areas for improvement.
Author and review controlled documents including SOPs, work instructions, validation protocols / reports and engineering specifications.
Support change control processes for validated systems, equipment and test methods.
Mentor and train junior engineers and quality staff on quality engineering principles and regulatory requirements.
Serve as a subject matter expert (SME) in quality process engineering during cross‑functional meetings and project reviews.
Perform and participate in other projects at the discretion of management.
Qualifications
Proven experience with medical devices, combination products and pharmaceuticals.
Strong knowledge of FDA QSR, ISO 13485, ISO 14971 and EU MDR.
Expertise in process validation, statistical analysis and quality tools.
Proficiency in quality software systems.
Strong analytical problem‑solving and project management skills.
Excellent communication and leadership abilities.
Experience in Lean Six Sigma and Lean Manufacturing principles.
Minimum 10 years of experience in Quality Engineering or Process Engineering in the medical device and / or pharma industry.
Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial or related field); master’s degree preferred.
As an employee of CooperSurgical you’ll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package: medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal sick and holidays and multiple other perks and benefits. Please visit us at learn more about CooperSurgical and the benefits of becoming a member of our team.
Key Skills Mac OS, Entertainment, Desktop Support, General Services, Account Development, Jewellery
Employment Type: Full-Time
Vacancy: 1
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability please contact us at
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Responsibilities
Lead initiatives to maintain and improve the Quality Management System (QMS) in compliance with FDA Quality Systems Regulations (QSR) ISO 13485 EU MDR and other applicable regulations.
Develop implement and maintain quality processes, procedures and metrics to ensure consistent product quality and regulatory compliance.
Support internal and external audits including but not limited to FDA ISO and notified body inspections.
Lead risk assessments (FMEA, Fault Tree Analysis) for new and existing processes.
Drive root cause analysis and corrective / preventive actions (CAPA) for process‑related nonconformances and complaints.
Monitor and report on quality metrics and trends to identify areas for improvement.
Author and review controlled documents including SOPs, work instructions, validation protocols / reports and engineering specifications.
Support change control processes for validated systems, equipment and test methods.
Mentor and train junior engineers and quality staff on quality engineering principles and regulatory requirements.
Serve as a subject matter expert (SME) in quality process engineering during cross‑functional meetings and project reviews.
Perform and participate in other projects at the discretion of management.
Qualifications
Proven experience with medical devices, combination products and pharmaceuticals.
Strong knowledge of FDA QSR, ISO 13485, ISO 14971 and EU MDR.
Expertise in process validation, statistical analysis and quality tools.
Proficiency in quality software systems.
Strong analytical problem‑solving and project management skills.
Excellent communication and leadership abilities.
Experience in Lean Six Sigma and Lean Manufacturing principles.
Minimum 10 years of experience in Quality Engineering or Process Engineering in the medical device and / or pharma industry.
Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial or related field); master’s degree preferred.
As an employee of CooperSurgical you’ll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package: medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal sick and holidays and multiple other perks and benefits. Please visit us at learn more about CooperSurgical and the benefits of becoming a member of our team.
Key Skills Mac OS, Entertainment, Desktop Support, General Services, Account Development, Jewellery
Employment Type: Full-Time
Vacancy: 1
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability please contact us at
#J-18808-Ljbffr