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Senior Supplier Quality Engineer
Requisition ID: 3217180209
Biosense Webster, Inc., a Member of Johnson & Johnson's Family of Companies is recruiting for a Senior Supplier Quality Engineer for its wholly subsidiary Coherex Medical, to be located in Salt Lake City, UT.
If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient’s lives and want to be responsible for providing the most innovative technology in the field of cardiac Left Atrial Appendage Closure, then Biosense Webster/Coherex Medical is the place for you!
Our products are used by prominent physicians around the world and help improve thousands of patient’s lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation – quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
You, the Senior Supplier Quality Engineer (SQE) provides overall quality assurance and quality engineering leadership in the management of contract manufacturing suppliers, including Finished Good Medical Devices, Direct and Indirect Material/Service Suppliers which can impact Johnson and Johnson production and/or sale of J&J product. You'll conduct day-to-day and strategic activities in the lifecycle management of suppliers. As a Sr. SQE, you will establish clear expectations and collaborate with internal and external partners that lead to consistent, reliable, quality products and services.
- Participate in the selection, categorization and qualification of suppliers and associated processes.
- Add, remove and update quality system supplier information and ensure accurate supplier information on the Approved Supplier List.
- Establish and provide relevant information detailed in supplier quality agreements and supplier change agreements.
- Execute and document supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs).
- You will define and lead actions related with Supplier Change Requests.
- Lead and support supplier assessments and supplier audits for compliance to regulations, agreements, standards and documented processes.
- Guide the development and improve comprehensive measurement systems for the SQ program and supplier quality performance. The Sr. SQE may report on such metrics at Quality System management reviews.
- Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects.
- Lead and document internal supplier quality procedure change efforts. The Sr. SQE will adhere/comply with and utilize multifaceted industry and process excellence standards on an expert level, including good manufacturing practices (GMP), equipment engineering system (EES), international organization for standardization (ISO) and country/governmental regulations. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
- Support local plant/facility based initiatives and projects.
- A Bachelor's Degree and a minimum of 4 years of experience in a GMP and/or ISO regulated industry is required.
- A Degree in Engineering, Life Science, or related discipline is preferred.
- Experience in the medical device and/or pharmaceutical industry is preferred.
- Experience in FDA and ISO regulations. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
- Auditing background is preferred.
- Strong communication, partnership, and analytical skills are required.
- Demonstrated strong root cause analysis skills are preferred.
- Six Sigma, Lean, or ASQ Certification and trainings are preferred.
- The position will be located in Salt Lake City, UT may require up to 20% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Utah-Salt Lake City
Coherex Medical, Inc. (6226)