Quality Assurance Manager
1 month ago
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.
- 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.
- B.Sc. in Chemical / Biochemical / Biotechnology / Materials Science Engineering or equivalent experience.
- Internal and Lead auditor certification.
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Quality Assurance Manager
3 weeks ago
Gilbert, Arizona, United States Cooper Companies Full timeJob DescriptionThe Cooper Companies is seeking a highly skilled Quality Assurance Manager to oversee all activities related to regulatory affairs and quality assurance for our SEC Sherbrooke site. This position is responsible for ensuring compliance with applicable regulations and maintaining current certificates.Key ResponsibilitiesManage and communicate...
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Quality Assurance Manager
3 weeks ago
Gilbert, Arizona, United States Cooper Companies Full timeJob Title: Quality Assurance ManagerJob Summary:We are seeking a highly skilled Quality Assurance Manager to join our team at Cooper Companies. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining current certificates.Key Responsibilities:* Manage and communicate with CVI management concerning all...
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Gilbert, Arizona, United States Cooper Companies Full timeCooperVision, a division of CooperCompanies, is a leading manufacturer of soft contact lenses. The company produces a range of daily disposable, two-week, and monthly contact lenses featuring advanced materials and optics.CooperVision has a strong heritage of solving vision challenges such as astigmatism, presbyopia, and childhood myopia. The company offers...
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