Quality Assurance Manager

5 days ago

Gilbert, Arizona, United States Cooper Companies Full time
Job Description

CooperVision, 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.

The QA Manager plays a critical role in ensuring compliance with regulatory requirements and maintaining current certificates. This position oversees all activities related to regulatory affairs and quality assurance for the CooperVision SEC Sherbrooke site.

Key Responsibilities
  • Manage and communicate with CVI management concerning major regulatory affairs and quality system issues related to manufacturing, design control, and compliance with applicable regulations.
  • Research, recommend, and implement best practices to contribute to both strategic and operational functions for the site.
  • Share responsibilities with the RAQA Specialist for the Person Responsible for Regulatory Compliance and EU Medical Devices Regulation (MDR) 2017/745 clauses.
  • Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews.
  • Prepare and complete action plans, implement production, productivity, quality, and customer service standards, identify and resolve problems, complete audits, determine system improvements, and implement change.
  • Write, review, and approve validation protocols for manufacturing equipment and processes.
  • Prepare and review changes to the Quality Manual, Device Master Records, and product technical files, communicating with all departments involved.
  • Manage the internal audit program at Paragon to ensure compliance with applicable regulations.
  • Review, evaluate, and resolve customer complaints for quality-related problems, implementing corrective actions as necessary.
  • Act as management representative for all FDA inspections, ISO audits, and other external audits.
  • Review and approve all new vendors related to the quality system, monitoring and assessing reported vendor performance problems.
  • Conduct purchasing of all QA inspectional equipment and supplies.
  • Manage all QA activities with regards to direct reports, final inspections, document control, and coordinates quality control activities with manufacturing.
  • Maintain and improve product quality by ensuring QA compliance, surveillance audits, investigating customer complaints, collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
  • Work closely with Marketing and Clinical Affairs to set priorities and strategies to meet business needs.
  • Keep ahead of US FDA, Canadian, EU MDR, and other applicable regulatory requirements and changes within the regulatory registration processes.
  • Advises management on future International regulations based on thorough knowledge of applicable regulations.
  • Reviews and approves Regulatory Assessment documents as required for post-market change control.
  • Collaborates with direct supervisor to create and manage department budget.
  • Builds, develops, and supervises quality and regulatory affairs staff, providing training and professional development opportunities to direct reports.
  • Provides guidance on regulatory requirements to strengthen scientific validity of submissions and receive timely product approvals, marketing clearances, and/or product registrations and licenses.
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.
  • B.Sc. in Chemical/Biochemical/Biotechnology/Materials Science Engineering or equivalent experience.
  • Internal and Lead auditor certification.
Travel Requirements

Up to 10% domestically and/or internationally.

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