Quality Engineer Principal

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.

• Provide advanced QA support and technical leadership for the MEVS operations, ensuring quality systems are effectively implemented and continuously improved.
• Act as a subject matter expert (SME) in one or more areas such as aseptic processing / sterility assurance, investigations and root cause analysis, and CAPA systems.
• Lead and/or facilitate complex investigations, NCMRs, and CAPAs, including root cause analysis, risk assessment, and effectiveness verification for the MEVS.
• Ensure compliance with applicable regulations and standards (e.g., 21 CFR 820, QMSR, ISO 13485, ISO 13408, EU MDR) by translating requirements into practical execution within assigned areas.
• Support inspection readiness activities, including backroom and front room support during inspections / audits and providing subject matter expertise input for responses and remediation. 
• Partner closely with Manufacturing, Engineering, QC, Supply Chain, and R&D to: resolve quality issues, implement corrective actions, and improve process capability.
• Analyze and trend quality data and metrics, identifying risks and recommending improvements to the value stream and site leadership.
• Support product disposition decisions through data review and risk assessment.
• Contribute to training, mentoring, and development of junior quality staff.
• Participate in Management Review preparation by providing data, trends, and technical insights.
• Support external interactions (e.g., audits, supplier engagement, limited industry participation) as needed.
• Perform other duties as assigned. 

 

Travel: 

This position may require 5-10% domestic or international travel. 

• Expert knowledge and practical application of 21 CFR 820, QMSR, ISO 13485, ISO 13408, and EU MDR.
• Strong aseptic/sterility assurance background, including contamination control strategy, environmental monitoring programs, and aseptic process simulation/media fill oversight aligned with ISO 13408 and global expectations.
• Demonstrated expertise leading complex deviations/nonconformances, investigations, and CAPA, including robust root cause analysis and effectiveness verification.
• Direct experience serving as a subject matter expert and leading responses for regulatory inspections and external audits (FDA and/or Notified Body), including front-room participation and written response ownership.
• Hands-on experience governing core QMS processes (CAPA, change control, document control, training, internal audits) and driving measurable continuous improvement.
• Strong analytical and communication skills, including the ability to translate data and quality risk into clear recommendations for site and global leadership.
• Fluent English required; Spanish proficiency strongly preferred (or ability and willingness to quickly develop working proficiency).

 

Work Environment:

• Onsite Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day. 
• Occasionally lift to 35 pounds.

 

Experience:

• 10+ years of progressive quality experience in regulated manufacturing, including medical devices, pharma, and /or biologics.

 

Education:

• Bachelor’s degree in Life Sciences, Engineering, or a related field (advanced degree a plus).
• Advanced degree or certifications (e.g. CQE, Six Sigma) preferred.