Quality Engineer

South Bay, CA

Posted: 08/08/2018 Employment Type: Temp To Perm Industry: Medical Device Job Number: JOS000007862

Quality Engineer/Associate Quality Engineer (Swing Shift)

The Company  is an ambitious, well-funded and fast-paced early stage biotech startup that is focused on developing novel diagnostic tests for infectious diseases. The Company is comprised of industry veterans and respected academics located in Silicon Valley. We are now looking to hire a Quality Engineer/Associate Quality Engineer. This position will report to the Director of Quality and Regulatory and work a swing shift from 3 pm – 11 pm.

 

The successful candidate is an enthusiastic, self-motivated individual with great communication skills who can support the development, implementation, and management of the Quality Management Systems to ISO 13485 and FDA QSR. The Quality Engineer will demonstrate a high level of individual responsibility and accountability.

Core responsibilities will include, but not be limited to:

  • Creating, updating, reviewing and developing Quality Management System standard operating procedures and supporting work instructions per ISO 13485 and FDA QSR.

  • Assisting personnel in use of Quality systems, tools, and techniques based on ISO 13485 and FDA QSR.

  • Performing root cause data analysis using statistical techniques.

  • Writing and performing qualification, verification/validation protocols under limited supervision.

  • Supporting the Internal Audit and Supplier Quality programs.

  • Providing support to manufacturing through batch record review and approval and on-line troubleshooting.

Education, Experience & Personal Qualities

  • BS in a STEM field required; Molecular Biology, Engineering, or related discipline strongly preferred.

  • Minimum of two years’ experience in a FDA regulated Medical Device industry required; Diagnostics experience preferred.

  • Start-up experience beneficial.

  • Professional certification in Quality Auditing, Quality Engineering, and/or Quality Management preferred.

  • Proactive approach, with high sense of urgency and results orientation.

  • Strong interpersonal skills, demonstrated ability to interface effectively on project teams.

  • High levels of integrity, honesty and maturity.

 

Compensation

  • Competitive salary, healthcare benefits & company stock options

  • Title based on candidate experience

 

Additional Information

 

  • We are currently prioritizing candidates who are local to the San Jose / San Francisco Bay Area.

  • Applicants must be currently authorized to work in the United States on a full-time basis.

 

The Company is driven by the belief that disease diagnoses should be quick, accurate, and accessible to all. We are developing a device platform that aims to redefine the way we test and treat illness. We are currently in stealth mode.

Company is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.

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