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Quality Systems Supervisor

 

Blackrock Microsystems is a privately held company that provides enabling tools for the neuroscience, neural engineering and neuro-prosthetics research and clinical community worldwide. The company is home to a diverse team of talented people who are dedicated to improving human lives. Working with Blackrock Microsystems gives you access to one of the most experienced, educated and forward-thinking electrophysiology teams in the world.

We are looking for a talented and skilled Quality Systems Supervisor to support the Quality/Regulatory department as required in all aspects of quality control, quality assurance, and regulatory compliance activities at our headquarters in Salt Lake City, Utah.

Requirements:

  • Bachelor degree in science or equivalent education in quality related courses.
  • ASQ Certification preferred
  • Minimum 5 years combined experience in QA or Manufacturing in the medical device/pharmaceutical industry. At least 5 years management experience.
  • Knowledge of FDA Quality System Regulation
  • Knowledge of ISO 9001/13485
  • Experience in establishing and maintaining quality system elements
  • Experience in auditing and FDA inspections
  • Excellent language skills including reading, writing and communication in the English language.
  • Excellent knowledge of Microsoft office applications such as Excel, Power Point, Visio, Word, Access, etc.
  • Organized, detail-oriented and methodical work habits.

 Duties and Responsibilities:

  • Formulates and maintains quality assurance objectives.
  • Official Correspondent for FDA facility registration and other matters
  • Management Representative
  • Liaison to outside regulatory consultants
  • Performs quality assurance reviews of design documentation for compliance with stated requirements, including company quality records.
  • Writes, reviews, approves company GMP-related policies and SOP’s.
  • Designs and implements quality assurance training programs.
  • Manages the Document Control and calibration process.
  • Lead Auditor.
  • Coordinates the CAPA, ECO and Nonconforming meetings and reviews.
  • Prepares quality metrics for management reviews.
  • In conjunction with Engineering, determines inspection characteristics for incoming, in-process and finished components and products.
  • Coordinates receiving inspection of components and contracted product.
  • Participates in 3rd party audits.
  • Performs quality assurance reviews of validation documents (protocols, technical reports, etc.)
  • Investigates customer complaints regarding quality.
  • Creates product labeling
  • Maintains a working knowledge of government and industry quality assurance codes and standards.
  • Performs other assignments as required by the Management.
  • Updates and maintains FDA UDI GUDID.

To apply, send your resume and a cover letter to jobs@blackrockmicro.com.
A video cover letter is preferred.

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