Johnson & Johnson Careers
Principal New Product Quality Engineer
Requisition ID: 2130180914
Johnson & Johnson Vision (JJV), a member of Johnson & Johnson's Family of Companies is recruiting for a Principal New Product Quality Engineer, to be located in Santa Ana, CA.
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 JV 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 Principal New Product Quality Engineer you will provide quality and technical leadership to ensure new medical devices (Capital Equipment, Accessories and Consumables) meet their intended use. You will be supporting the design, development, testing, launch and monitoring of Lens Insertion Systems, Phaco surgical systems and Ophthalmic Viscoelastic Devices.
Your responsibilities will include:
- Quality leadership on new product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
- Quality leadership on new product validation programs to ensure they are well-defined, executable, meet customer and business needs, and are in compliance with regulatory requirements.
- Subject matter expertise in design controls, risk, validation principles, and related statistical techniques.
- Partners with new product project teams to ensure compliance with current quality system procedures including risk management, design controls, and process validation.
- Ensures effective risk management to prevent failure modes and improve capability of processes
- Proactively examines systems, processes, and standards to identify areas for review, change, or elimination.
- Owns CAPAs and drives root cause investigations.
- Supports the development of more junior staff and advise management on technical matters
- Conducts quality evaluation for the development and validation of test methods.
- Collaborates with functional business partners to proactively address quality issues during new product development and product verification/validation. Ensures process capability with respect to product specifications.
- Adheres to safety and environmental policies and procedures and supports departmental safety and environmental objectives.
- Leads/manages validation activities/projects. Develops testing strategies based on requirements and designs. Creates/reviews and/or approves product/process, software, utilities, equipment, and facilities, validation documentation.
- Investigates product issues. Collaborates with R&D and PM to identify root causes.
- Refines the Design Controls and other supporting processes.
- BS Degree in Engineering is required, Masters Degree is preferred
- 10+ years of working experience in the Quality Engineering and/or R&D groups (required)
- 5+ years of experience in the Medical Device industry (preferred)
- 5+ years of experience supporting the design and development of electro-mechanical Capital Equipment, mechanical devices, and/or Consumables (required)
- 5+ years of experience managing risk assessment sessions and Design Verification & Validation activities (preferred)
- Excellent understanding of statistical techniques, Usability Engineering and Reliability Engineering (preferred)
- Working knowledge of cleaning and sterilization, stability, biocompatibility and/ or Process Validation is a big plus (preferred)
- Knowledge of 21 CFR 820 as well as 21 CFR 210 and 211 (preferred)
- Must have the ability to read drawings and calculate tolerance stack-ups. (preferred)
- Must have excellent communication, interpersonal and leadership skills. (required)
- Experience presenting quality records to an Auditor (preferred)
- ASQ CQE and other Certifications are preferred (preferred)
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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