Principal Quality Process Engineer

CooperSurgical is a leading fertility and womens 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 CooperCompanies were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

• 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.

• 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.
• Bachelors degree in engineering (Mechanical Biomedical Industrial or related field); masters degree preferred.

As an employee of CooperSurgical youll 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.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

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