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Senior Manager, Quality Assurance Management

CooperSurgical
HENRIETTA, NY Full Time
POSTED ON 1/24/2025
AVAILABLE BEFORE 2/6/2025

Job Title: Quality Management Representative

CooperVision, a division of CooperCompanies, is a leading manufacturer of soft contact lenses. The company produces daily disposable, two-week, and monthly contact lenses featuring advanced materials and optics.

Job Summary:

The Quality Management Representative will ensure effective and consistent definition and execution of the Quality management system through identification, development, and application of core competencies required to deliver excellent compliance and quality controls.

Responsibilities:

  • Develops, implements, and maintains the Quality Management System and quality assurance procedures required to ensure processes and products comply with applicable quality standards and regulatory requirements.
  • Oversees the development of Standard Operating Procedures (SOPs), processes, supporting documents, and training materials for quality assurance, global packaging, supply chain, and distribution activities.
  • Supports NCR and CAPA processes, collaborating with process owners to ensure effective root cause analysis and long-term solutions.

Requirements:

  • Minimum 10 years' experience in Quality Assurance with management experience, preferably in medical device manufacturing or other regulated industry.
  • Proven experience of working to local and international regulations, including risk management principles.
  • Bachelor's degree required; engineering or technical field preferred.

Estimated Salary:

$124,444 - $177,777 per year, depending on location and qualifications.

Travel Requirements:

Domestic and international travel may be required up to 10% of the time.

Salary : $124,444 - $177,777

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