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Quality Systems Specialist

 

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 Specialist 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’s degree preferable in sciences or quality/regulatory
  • Minimum 3 years medical device experience; or equivalent combination of education and experience
  • ASQ Certification preferred

 Desired Qualifications:

  • Knowledgeable in FDA and international regulations relevant to each project, i.e. FDA GMP, ISO 13485, ISO 14971, Canadian Medical Device Regulations (CMDR) and Medical Devices Directive (MDD).
  • Familiar with internal auditing and FDA/ISO facility inspections.
  • Knowledge of sterilization activities a plus.
  • 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.
  • Experience in engineering and manufacturing environments preferred.
  • Experience in quality audits preferred.

Duties and Responsibilities:

  • Assist with maintenance of the applicable procedures and instruction.
  • Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
  • Participate in process validation activities.
  • Control and maintain current Device Master Documents on the production floor.
  • Participate in risk management meetings and related activities such a verification of risk mitigation implementation in products and processes.
  • Provide support for the supplier management program.
  • Participate in product failure investigations and ensure adequate documentation and review are conducted for Non-conforming products.
  • Perform product inspections to specified requirements.
  • Review, maintain and archive Device History Records.
  • Handle customer returns according to Return Good procedure.
  • Handle non-conforming products, documentation and reports as per current Non-Conformance procedure
  • Conduct Internal Quality Audits and support the audit programs as needed.

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

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