Quality Engineer

Immediate 3 month+ contract opportunity for a seasoned Quality Engineer located in the Union City area of northern, California! The Quality Engineer will work in a Quality Systems/ Assurance environment to ensure that the design, development, manufacturing and support of medical products meet the requirements of ISO13485, 21 CFR 820 and other applicable Quality Standards. This position requires a bachelor's degree in Engineering field and a minimum of five years Quality/Regulatory and ASQ certification or equivalent. Come and join a great team and take your Engineering career to the next level!

RESPONSIBILITIES

- Oversees all aspects of the Validation Program ensuring compliance, has primary responsibility for product and process validation consistent with customer requirements. Writes and deploys IQ/OQ/PQ protocols and validation reports
- Plays a key role in implementing and executing company's Quality System in accordance with ISO13485 /21 CFR 820 standards
- Troubleshoots process and equipment validation issues by working closely with manufacturing and development to resolve
- Makes presentations at departmental meetings and assists in the preparation of product documentation and technical presentations

REQUIREMENTS

- Bachelor's degree in Science or Engineering field and a minimum of five years Quality/Regulatory or related work experience
- Strong analytical and organization skills as well as a methodical approach to data driven problem solving
- Excellent writing skills for report preparation. Good verbal communications as well as good interpersonal skills
- Experience with ISO13485 and cGMP/QSR regulations and requirements / ASQ certification or equivalent highly desirable
- 6 Sigma training or certification a plus
- Must have the ability to review and evaluate scientific and technical standards and translate those requirements into efficient, effective internal processes as they pertain to Quality Systems