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.
- 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 email@example.com.
A video cover letter is preferred.