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.
- 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
- 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 firstname.lastname@example.org.
A video cover letter is preferred.