Quality Assurance Manager

6 days ago


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

CooperVision, a leading manufacturer of soft contact lenses, is seeking a Quality Assurance Manager to oversee all activities related to regulatory affairs and quality assurance for the CooperVision SEC Sherbrooke site. The successful candidate will ensure compliance with applicable regulations and maintain current certificates.

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 contribute to both strategic and operational functions for the site.
  • Share responsibilities with the RAQA Specialist for the Person Responsible for Regulatory Compliance and ensure compliance with Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745.
  • Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews.
  • 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.
  • Manage the internal audit program to ensure compliance with applicable regulations.
  • Review, evaluate, and resolve customer complaints for quality-related problems.
  • Act as management representative for all FDA inspections, ISO audits, and other external audits.
  • Review and approve new vendors related to the quality system.
  • Monitor and assess reported vendor performance problems.
  • Manage all QA activities, including direct reports, final inspections, document control, and coordinates quality control activities with manufacturing.
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.
  • 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.
Work Environment:

The Quality Assurance Manager will work in a normal office environment, sitting and working on a computer for long periods. The role requires light lifting of documents, files, and reference books, as well as generating large volumes of documents in a fast-paced environment.



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