Director Quality Assurance - Global - Medical Device

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Posted Under: Clearwater, Florida jobs in Executive; Executive jobs in zipcode 34630
Posted On: 2019-10-10

Love your job!Due to the growth of the business, our Clearwater based medical products client is in search of a top notch Global Director of Quality Assurance. Excellent salary, bonus package, benefits and relocation package are available!This is an amazing area to live in. Endless summer. Low cost of living (including NO state income tax!), and a high quality of life.Reporting to the VP, Quality Assurance & Regulatory Affairs, the QA Global Director is responsible for all aspects pertaining to Quality Assurance for all client sites. This position, as a key member of the leadership team, requires both strategic and operational capabilities in developing and improving formal quality operational processes and procedures, working with manufacturing, operations and development teams to ensure the quality of products designed and manufactured.
The Global Director of Quality Assurance will
  • be responsible for creating functional strategies and specific objectives for quality assurance
  • develop budgets/policies/procedures to support the functional infrastructure
  • coordinate with various internal departments to assure operational and procedural compliance with state, federal and international regulations
  • work closely with other functions of the company, including regulatory affairs, manufacturing, operations, facilities, purchasing, research & development, clinical affairs, medical affairs, sales & marketing, operations and finance
  • more fun and impactful things!REQUIREMENTS
    • A Bachelor's or Master's degree in scientific, health care, or related field or equivalent.
    • Minimum of (7+) years in Quality Assurance leadership roles including direct, industry-related quality experience within the medical device industry.
    • Must have demonstrated experience/knowledge of Quality Assurance, Quality Systems, MDD (EU-MDR), ISO, MDSAP requirements and medical device industry regulations, such as--FDA 21CFR820, ISO13485
    • 15 years' experience in a regulated medical manufacturing environment with Senior Leadership experience is required.

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