Quality Assurance Manager

1 month ago


Gilbert, Arizona, United States Cooper Companies Full time
Job Title: Quality Assurance Manager

CooperVision, a division of CooperCompanies, is a leading manufacturer of soft contact lenses. We are seeking a Quality Assurance Manager to oversee all activities related to regulatory affairs and quality assurance for our CooperVision SEC Sherbrooke site.

Key Responsibilities:
  • Manage and communicate with CVI management concerning all major regulatory affairs and quality system issues related to manufacturing, design control, and compliance with applicable regulations.
  • Research, recommend, and implement best practices to ensure compliance with regulatory requirements.
  • Collaborate with direct supervisor to create and manage department budget, including obtaining quotes for consultants, predicting costs for future submissions, and managing costs to stay within defined budget.
  • Build, develop, and supervise quality and regulatory affairs staff, providing training and professional development opportunities.
  • Interview, hire, and train employees, plan, assign, and direct work, appraise performance, reward and discipline employees, and address complaints and resolve employee problems.
Requirements:
  • Minimum of 5 years of experience in the Medical Devices Industry.
  • Strong knowledge of regulatory requirements related to product registration processes for Medical Devices.
  • Application of quality system and regulatory requirements from product concept through product distribution.
  • Working knowledge of interacting with regulatory entities, notified bodies, and other external regulators.
  • Contact Lens experience is highly desirable.
  • Works effectively across different cultures and languages.
  • Strong technical acumen, computer skills, problem-solving ability, analytical, writing, and communication skills.
Education:
  • B.Sc. in Chemical / Biochemical / Biotechnology / Materials Science Engineering or equivalent experience.
  • Internal and Lead auditor certification.


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