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Manager of Quality Systems

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International Diagnostics Corporation with 40+ years of successful Research, Development and Manufacturing of Immunoassay Diagnostic Test Kits is looking to identify and hire a Manager of Quality Systems on a direct hire basis.

The Manager of Quality Systems will be responsible for, but not limited to:

Regulatory:

  • Ensuring compliance to all regulations referred to in Quality Manual.
  • 510K Filings.
  • Registering all products before they are sold.
  • Completing declaration and safety / efficiency of products.
  • International Regulatory Filings:
    • Technical Files-CE
    • Canadian Device License
    • Other filings as required
  • Responsible for Device Listings with FDA.

Annual tasks:

  • Registering with FDA, State & Federal Inspections.
  • Certification and surveillance audits from notified body for ISO/CE.
  • Interfacing with inspectors.
  • Interacting with environmental regulators & OSHA.
  • Notifying President of changing regulatory requirements.

Quality:

  • Interfacing new programs to meet requirements for worldwide quality standards/ ISO.
  • Interfacing with Directors of Manufacturing and Marketing.
  • Managing Internal Audit Program.
  • Completing reports.
  • Acting as Chairperson to discuss audits, reports, corrections needed, and final determinations.
  • Reviewing Quality Procedures to sign off on their authenticity and status.
  • Managing Document Control System.
  • Managing Training Program.
  • Implementing changes needed to achieve compliance to ISO standards.

Job Requirements:

  • Minimum Bachelor’s degree in science related field.
  • 3-5 years’ experience in a quality management level role, working within a medical device or IVD manufacturing industry.
  • Experienced in leading regulatory audits.
  • Experience in Quality Systems, ISO 13485 and FDA Requirements.
  • Experience with CAPA programs, deviation reporting, and document control.
  • Excellent written and verbal communications skills.
  • Basic computer skills (Word, Excel).
  • Ability to think strategically.

 

 

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