Manager, Quality Assurance

The Life Science 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. This position will be expected to work collaboratively with other functions of the organization to meet project goals, timelines, and audit success. The Quality Manager is also responsible for actively growing, coaching, and supporting the quality team’s professional development. The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain feedback. The candidate should have skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset. 

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.

Essential Functions & Accountabilities:

• Responsible for day to day oversight of the following Quality System Components:
  • Quality Events (Deviations, Nonconformance, Change Control) 
  • CAPA 
  • Complaint handling and resolution 
  • Document Control 
  • Training Program
  • Process and Continuous Improvements
  • Management Review
  • Tracking and trending of Quality Metrics
• Support of External inspections performed by notified bodies for HQ and Donor Collection sites
• Internal Audits – response acceptance and review, conducting process internal audits as needed basis
• 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 coordinates 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 inspections (internal and external) 
• Assists in implementation of regulatory changes impacting quality systems and support for quality. 
• Establish and implement consistent metrics for monitoring system effectiveness to enable Quality customers to make sound quality decisions and drive continuous improvement. 
• Clearly communicate quality issues, identified risks, continuous improvements opportunities and corrective actions throughout affected departments and leadership teams
• Performing compliance review and approval on executed records for completeness of all required testing, verification of documents for various processes
• Perform other Quality Assurance tasks as required. 

Supervisory Duties:

• Lead and coach individuals within the Quality Team. Conduct ongoing performance acceleration/ evaluation assessment and provide feedback to employees in order to help optimize their and the teams overall performance
• Mentor the team and actively identifies professional development opportunities
• Creation of a training program for Personnel development
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.  

Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Proactively mentor and provide resource for personnel professional development

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Qualifications

Knowledge, Skills and Abilities:

• Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
• Familiarity or experience with the following is strongly preferred: Basic s