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    Manager, Quality Assurance - Tucson, United States - CooperCompanies

    CooperCompanies
    CooperCompanies Tucson, United States

    3 weeks ago

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    Full time
    Description

    About CooperSurgical

    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 .

    The Life Science Quality Assurance Manager will report to the Life Science Quality Director. The Manager oversees the day-to-day operations of the Quality Management System (QMS) driving continuous improvement and quality improvement initiatives withing the organization that have been identified within the QMS programs. The role is essential to cultivating an open, collaborative, and engaging quality culture.

  • Responsible for day to day oversight of the following Quality System Components: Quality Events (Deviations, Nonconformance, Change Control) CAPA o Complaint handling and resolution Supplier Quality Document Control Records Management o Document Training
  • 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.
  • Hybrid (3-4 days a week onsite)

    • 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
  • 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.
  • Bachelor's Degree in Science or a related discipline and five to seven years related experience and/or training or Associates degree ( with eight to ten years related experience and/or training; or equivalent combination of education and experience.
  • Candidate should demonstrate knowledge of regulations and standards such as: CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 Medical Laboratories AABB, FDA (HCT/P, cGMP, cGTP), 21CFR1271 and ISO regulations
  • Identifies ways to improve processes/situations Job Description
  • Takes responsibility for improvements or solving problems.
  • Must display eagerness to learn and continuously improve.
  • Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal Skills
  • Socially capable - interacts confidently, reads the situation
  • Empathetic and can evaluate likely reactions
  • Collaborative approach

    • As an employee of CooperSurgical, you'll 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 to 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 place. 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.

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