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Quality Assurance Director
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Quality Assurance Director

Posted 16 February by TEC PARTNERS LIMITED
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Salary icon USD$130,000 - USD$150,000 per annum

TEC Partners is pleased to have partnered with a leader of innovation, development, and manufacturing solutions to the pharmaceutical and medical device industries. As one of the largest suppliers in the Life Science arena on a global scale, my client works closely with customers to provide highly engineered products that help millions live healthier lives!

Quality Assurance Director:

  • Provide direction and leadership to the Quality teams including people management.
  • Maintain and improve quality systems to support the Strategic Plan for new business opportunities
  • Ensure compliance with medical device and pharmaceutical regulations and quality system requirements.
  • Work with the Commercial team to represent Quality System with customers and potential customers
  • Work with management on risk assessment and regulatory compliance
  • Drive Continuous improvement activities
  • Provide expertise for the continuous improvement of the quality system as it pertains to combination products

Quality Assurance Director Requirements:

  • B.S. degree in quality, business, or engineering field
  • Ten (10) years or more experience in a quality role within medical devices
  • Five (5) years or more experience in a management role
  • Knowledge of FDA and international regulations and ISO standards related to medical device design and manufacturing (e.g., MDR, 21 CFR 11, 820, 211, and ISO 13485, 14971)
  • Direct experience with audits and pre-approval inspections by regulatory authorities

If you are passionate about quality, compliance, and driving excellence in the medical device sector, please apply with an up to date CV.

Required skills

  • 1
    CAPA
  • 1
    Quality Assurance
  • 1
    Quality Management Systems
  • 1
    NCR
  • 1
    Internal and External Audit

Reference: 52146604

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