Senior Quality Engineer Job in Menlo Park, California US
Acclarent, Inc., a member of Johnson Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty devices. Through the Balloon Sinuplasty technology and our Relieva product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.
Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT.
The Senior Quality Engineer will be responsible for production quality. This individual will serve as the primary contact within the company and with suppliers with quality related issues. Activities include MRB, incoming and final inspection, acceptance testing, and other tasks as assigned. This individual will lead and participate in NCMR activities. The Senior Quality Engineer will identify non-conformance trends and implement corrective action programs both internally and at the supplier. This individual will evaluate and lead improvements for in-process inspection, test methods and inspection equipment.
The Senior Quality Engineer will develop and maintain SPC program and evaluate the results for continuous improvement. This individual will support in process validation and support production line transfers to contract manufacturer including the development of quality plans. The Sr. Quality Engineer will oversee and develop sampling plans for lot release testing. This individual will conduct failure investigations, identify and implement suggestions for improvement. The Senior Quality Engineer will continuously identify and implement best-in-class quality practices and will promote and maintain an environment that ensures compliance to QSR, ISO, and Acclarent policies and procedures.
Qualifications
A minimum of a Bachelor's degree or equivalent plus a minimum of 5 years of Quality Engineering experience in medical devices is required. Knowledge of quality/continuous improvement tools (ex: SPC, Statistics, DOE, Six Sigma) is required. It is required to have strong written and oral communication skills. A demonstrated ability to identify and implement best practices within a production environment is required.
It is preferred to have experience in Quality supporting an Operations environment. It is preferred that this candidate have experience supporting line transfers to another site including transferring manufacturing process and related inspection activities. Six Sigma Green or Black Belt Certification is preferred. Lead auditor training is a plus. Previous experience managing technicians or contractors is preferred.
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