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Staff Engineer, External Mfg. & Supplier Quality
Requisition ID: 2090171031
Johnson & Johnson Vision, a member of the Johnson & Johnson family of companies, is recruiting for a Staff Engineer, External Mfg. & Supplier Quality to be located in Santa Ana, CA.
Johnson & Johnson Vision (JJV), is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the J&J Vision brands brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
As the Staff Supplier Quality Engineer, you will be responsible for providing overall quality assurance leadership in the management of select supplier sites. You will identify and eliminate supply chain risks via EM/vendor partnerships & assessments and ensure suppliers technical competency and general compliance adhere to company requirements as defined in material specifications, CTQ’s, process control plans, quality agreements and other defined requirements. Key areas of focus within supplier management are risk management/communication, defect resolution, process capability/process improvement, performance monitoring/reporting, and quality assurance general support. Additionally, you will provide regulatory guidance and quality assurance support, support for external manufacturing activities and completing department and franchise objectives as assigned.
In this role, you will be responsible for the following:
- Activities associated with resolving supplier quality issues.
- Work with supplier and JJV resources to perform root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.
- Activities associated with supplier risk management.
- Work with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans.
- Participate in supplier risk management projects; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
- Activities associated with supplier process improvement.
- Work with suppliers to identify sources of variation within their processes.
- Implementing process controls to improve process capability; and driving implementation of best practices.
- Develop and report on supplier performance metrics.
- Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives.
- Perform and Support supplier/ EM quality evaluations and/or audits
- Develop quality agreements, and other quality related activities impacting supplier.
- A minimum of 7+ years of experience in a highly-regulated industry is required
- A minimum of 2 year of experience with CAPA’s and NC’s is required
- FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required
- Auditing background is an asset
- Strong statistical skills are preferred
- Strong in root cause analysis skills is required
- Experience or knowledge with machining, chemical manufacturing processes and injection molding an asset
- Six Sigma, Lean or ASQ CQE Certification and trainings an asset
- Experience with Quality Audits is preferred
- Strong communication, teamwork, and problem solving skills is required
- Ability to speak and read Spanish is a plus
- This position will be located in Santa Ana, CA and will require up to 30% 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-California-Santa Ana
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