Senior Supervisor, Quality Engineering
About The Position
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 CooperCompanies, we're 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 www.coopersurgical.com.
Requirements
- Experience with applicable U.S. and international regulatory requirements (e.g., 21 CFR Parts 210, 211, 820, and ISO 13485).
- Proficiency in investigation methodologies, root cause analysis, and risk management principles.
- Experience with Quality Management System (QMS) processes, including investigations, nonconformance management, CAPA, and compliance activities.
- Ability to evaluate outcomes to determine appropriate escalation actions such as CAPA initiation, risk assessments, trend analysis, and regulatory reporting.
- Experience in leading cross-functional collaboration.
- Experience in verifying investigation conclusions and corrective actions.
- Experience in maintaining the integrity of quality system documentation.
- Experience supporting audit readiness.
- Experience coaching and mentoring QA personnel.
- Experience promoting consistent quality practices.
- Experience serving as a subject matter expert during internal and external audits and inspections.
- Experience developing and presenting quality metrics and trending analyses to leadership.
- Experience driving continuous improvement of QMS processes based on data insights, risk signals, and evolving regulatory expectations.
Responsibilities
- Providing strategic oversight and leadership of Quality Management System (QMS) processes, including investigations, nonconformance management, CAPA, and compliance activities in accordance with applicable U.S. and international regulatory requirements (e.g., 21 CFR Parts 210, 211, 820, and ISO 13485).
- Ensuring consistent, compliant, and risk-based execution of quality processes through effective application of investigation methodologies, root cause analysis, and risk management principles.
- Accountable for process quality, prioritization, escalation decisions, and inspection readiness, driving cross-functional alignment and continuous improvement to support product quality, regulatory compliance, and patient safety.
- Overseeing and directing key quality system processes, ensuring timely, thorough, and compliant handling of quality events, including deviations, nonconformances, complaints, and audit observations.
- Responsible for the intake, review, prioritization, assignment, and approval of investigations and quality records.
- Evaluating outcomes to determine appropriate escalation actions such as CAPA initiation, risk assessments, trend analysis, and regulatory reporting.
- Leading cross-functional collaboration with Quality, Regulatory Affairs, Manufacturing, R&D, Supply Chain, and external partners to drive effective issue resolution, risk mitigation, and process alignment.
- Ensuring verification of investigation conclusions and corrective actions.
- Maintaining the integrity of quality system documentation.
- Supporting audit readiness.
- Coaching and mentoring QA personnel.
- Promoting consistent quality practices.
- Serving as a subject matter expert during internal and external audits and inspections.
- Helping develop and present quality metrics and trending analyses to leadership.
- Driving continuous improvement of QMS processes based on data insights, risk signals, and evolving regulatory expectations.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
