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SR. SUPPLIER QE-7247130501
Acclarent, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Supplier 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 Sr. Supplier Quality Engineer (SQE) will support Acclarent's supplier quality management process and will act as one of the primary contacts with suppliers on all quality related issues during both the supplier maintenance and supplier selection process. This individual will provide support for all supplier management activities, interactions, and continuous improvement initiatives. They provide supplier related support to production and receiving inspection teams and will lead to resolve any non-conformity that is resulted due to supplier performance. The Sr. SQE is in charge of monitoring parts from acquisition through the inspection and manufacturing cycle, and is responsible to communicate and resolve supplier-related process problems as they occur through the MRB process.
The Sr. SQE participates in selection of suppliers in the design and development phase as well as the production phase to ensure that the supplier's current and future capabilities will meet the company's needs. This individual develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP's, ISO 13485, and company's quality standards are met. They will act as the Supplier quality representative on Design and Development teams, and ensures that the supplier selection process is followed in accordance to the company guidelines. The Sr. SQE will conduct Supplier Scorecard review to assess suppliers on their ability to meet quality, delivery, and service targets. They also will conduct Supplier audits and ensure supplier implements and maintains any resulting corrective action program, through the SCAR program, and ensure timely closure of SCARs by suppliers.
The Sr. SQE will audit and evaluate suppliers' internal processes to assess their overall compliance to the organization and regulatory requirements, including the monitoring of sub-suppliers, and provides feedback to improve their operation.
This individual will develop world class Suppliers Management Program through the use of Six Sigma and Lean methodologies. They will develop and maintain SPC program and evaluate the results for continuous improvement and assist suppliers in process validation. The Sr. SQE will support product transfers to contract manufacturing sites, and participate in development of required Quality Plans, and protocols.
They will be responsible for mentoring and training of new department members. The Sr. SQE will support the development of supplier related Quality metrics for presentation to Sr. Management on a monthly basis as well as during the Management reviews.
A minimum of a Bachelor's degree in a related technical discipline along with a minimum of 5 years of quality engineering experience in the medical device industry is required. Experience with Supplier Quality and Quality System requirements in medical devices industry is required.
It is required to have Lead Auditor certificate (CQA) with previous auditing experience. CQE preferred. Excellent verbal and written communication and interpersonal skills, demonstrated leadership skills and problem solving abilities are required. A demonstrated knowledge of quality/continuous improvement tools such as SPC, Statistics, DOE is preferred. Six Sigma Green or Black Belt certification is preferred. It is required to have a strong working knowledge of Microsoft Word, Excel and PowerPoint including developing graphs and presentations.
This position will require a minimum of 30 % travel and is located in Menlo Park, CA.
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Primary Location: North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job Function: Quality (Eng)
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