Senior Manager, Quality Systems

The Life Science Senior Quality Manager is responsible for all aspects of Quality Assurance including but not limited to: compliance with applicable regulations and standards, assist in post market surveillance activities and continuously monitoring the organization identifying opportunities for improvement and alignment. 

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

• ☐ Responsible for day-to-day oversight of the following Harmonized Quality Management System :
  • Quality Events (Deviations, Nonconformance, Change Control and Corrective and Preventive Action)
  • Complaint handling, monitoring and resolution 
  • Supplier Quality 
  • Document Control, Records Management, and Document Training 
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  • Adverse event reporting
  • Continuous Improvement: Identifying areas for improvement in validation and compliance processes and implementing corrective actions. Develop, implement, maintain, and continually assess the Company’s QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements.
  • Develop, implement, maintain, and continually assess the Company’s QC function and Quality Management System (QMS) for applicable regulated activities to meet internal company standards and external global regulatory requirements. 
  • Training and Development: Designing and implementing training programs for staff Quality Assurance Team members for the day-to-day management. Additionally creating and implementing a training program for organizational staff to ensure understanding of the Quality Management System and process for compliance.
• ☒ Responsible for day-to-day oversight of the following Quality Control System:
  • Validation and equipment
    • Responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability.
    • Training and Development: Designing and implementing training programs for staff on validation and compliance procedures.
  • Reagent Quality Control:
• Lead investigations and resolution of findings impacting the product identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalations.
• Leads and participates in cross-departmental/organizational teams. Accountable for quality control support of new product integration, stability program, process development, equipment and process validations, as well as meeting production schedules.
• Metric Reporting Program: 
  • Establish, manage, track, trend and deliver timely reporting of departmental performance metrics and statistical process controls; drive actions as required.
• ☐ Audit and Inspection Support: Supporting internal and external audits and inspections to ensure compliance with regulatory standards. 
• ☒ Project Management: Lead or participate in sustaining projects for improvement of processes, global harmonization, infrastructure, product specifications, process/test methods, analysis tools, and business systems.
• Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Lead the implementation of a robust Quality System that will ensure premium patient care delivering internal and external customer satisfaction. 
• Manage and coordinate all aspects of quality working at all levels of the organization as necessary to implement policies and procedures necessary for quality requirements. 
• Represent and own quality corporate functions including, but not limited to: Management Review, Core Team member on projects and inspection response (internal and external) 
• Assists in implementation of regulatory changes impacting quality systems and support for quality. 
• Knowledge of Risk Management principles including the use of risk management techniques
• Establish and implement consistent metrics for monitorin