Johnson & Johnson Vision Care, Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Staff New Product Quality Engineer to be located in Jacksonville, FL.
Johnson & Johnson Vision Care (JJVC) manufactures ACUVUE® brand contact lenses, the world's first soft disposable contact lens, and is headquartered in Jacksonville, Florida. JJVC 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, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry.
The Staff New Product Quality Engineer provides quality and technical leadership to ensure new medical devices meet their intended uses. This position provides quality leadership on new product project teams and ensures the Critical to Quality (CTQs) attributes, and cascading requirements are established, implemented and validated. Additionally, this position oversees the test method program.
The Staff New Product Quality Engineer:
- Partners with new product project teams to ensure requirements development are traceable to User Needs/Clinical Measures and measurable performance characteristics.
- Leads the quality strategy for the process validation of new product introductions, ensuring that they are well-defined, meet customer needs and are in compliance with requirements.
- Provides quality and technical leadership to ensure that test methods are developed, qualified and/or validated meet their intended use.
- 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.
- Ensures compliance with current quality system procedures including risk management, design controls, CTQ Flowdown, and test method validation.
- Adheres to safety and environmental policies and procedures and supports departmental safety and environmental objectives.
- Provides technical leadership and quality oversight to test method validations.
- Provides quality and technical guidance to new product development project teams across various platforms throughout the Development and Transfer Lifecycle.
- Leads activities associated with risk management. This includes partnering with development associates to identify areas of risk, and to establish risk mitigation plans.
- Implements system changes to improve the accuracy and efficiency of the new product introduction process.
- Performs other related duties as assigned by management.
A minimum of a Bachelor’s Degree in Engineering, Science, Statistics or other related technical discipline is required; an advanced degree is an asset.
A minimum of six (6) plus years working experience in Process or Quality Engineering/Statistics in a Regulated Industry, and/or medical device industry is required.
Pharmaceutical experience preferred.
Test Method Validation experience is required
Thorough understanding of QSR/ISO regulations especially design controls, risk management, and validation principles are required.
Excellent understanding and application of principles, concepts and practices of statistical methods are required.
Six Sigma, Lean or ASQ CQE Certification and training are preferred.
Excellent communication, interpersonal and organizational skills are required.
Strong leadership and coaching skills are required.
This position may require up to 10% domestic and international travel and will be based in Jacksonville, Florida.
Johnson & Johnson Vision Care, Inc. (6094)Job Function