Senior New Product Quality Engineer
Johnson & Johnson Vision Care, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior 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 Senior New Product Quality Engineer provides quality and technical leadership to ensure new medical devices meet their intended uses. This position has increased scope and responsibility for participation on project teams or leadership of quality related projects in comparison to the New Product Quality Engineer role.
Senior New Product Quality Engineer responsibilities may include but are not limited to the following:
provides quality strategic leadership on new product project teams and ensures the Critical to Quality (CTQs) attributes, cascading requirements (for product, process, raw materials and test methods) are established, implemented and validated.
serves as quality assurance representation on project teams to ensure the implementation of quality system requirements (e.g. JJVC Quality Systems, cGMP, ISO Standards, etc.).
leads validation projects by developing and delivering on the qualification strategy related to processes, test methods and automated systems associated with new product introductions.
leads or supports R&D Supplier Quality activities including supplier auditing and evaluation.
collaborates with functional business partners to proactively address quality issues during new product development and product verification/validation by ensuring process capability with respect to product specifications.
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 4-7 years working experience in Process or Quality Engineering or Statistics in a regulated industry is required.
Excellent understanding and application of principles, concepts and practices of statistical methods, validation methods, design controls, risk management and quality auditing is required.
Working experience in computerized system validation is an asset.
Knowledge, understanding and application of principles, concepts and practices of QSR/ISO regulations, GEP, and GAMP is required.
Knowledge of 21 CFR 820 as well as 21CFR 210 and 211 is an asset
Excellent communication, interpersonal, conflict management and organization skills.
Six Sigma, Lean or ASQ CQE Certification and training are preferred.
Membership in and Certifications from ASQ, IEEE, and /or ISPE are encouraged
This position may require up to 10% domestic and international travel and will be based in Jacksonville, Florida.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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 Senior New Product Quality Engineer provides quality and technical leadership to ensure new medical devices meet their intended uses. This position has increased scope and responsibility for participation on project teams or leadership of quality related projects in comparison to the New Product Quality Engineer role.
Senior New Product Quality Engineer responsibilities may include but are not limited to the following:
provides quality strategic leadership on new product project teams and ensures the Critical to Quality (CTQs) attributes, cascading requirements (for product, process, raw materials and test methods) are established, implemented and validated.
serves as quality assurance representation on project teams to ensure the implementation of quality system requirements (e.g. JJVC Quality Systems, cGMP, ISO Standards, etc.).
leads validation projects by developing and delivering on the qualification strategy related to processes, test methods and automated systems associated with new product introductions.
leads or supports R&D Supplier Quality activities including supplier auditing and evaluation.
collaborates with functional business partners to proactively address quality issues during new product development and product verification/validation by ensuring process capability with respect to product specifications.
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 4-7 years working experience in Process or Quality Engineering or Statistics in a regulated industry is required.
Excellent understanding and application of principles, concepts and practices of statistical methods, validation methods, design controls, risk management and quality auditing is required.
Working experience in computerized system validation is an asset.
Knowledge, understanding and application of principles, concepts and practices of QSR/ISO regulations, GEP, and GAMP is required.
Knowledge of 21 CFR 820 as well as 21CFR 210 and 211 is an asset
Excellent communication, interpersonal, conflict management and organization skills.
Six Sigma, Lean or ASQ CQE Certification and training are preferred.
Membership in and Certifications from ASQ, IEEE, and /or ISPE are encouraged
This position may require up to 10% domestic and international travel and will be based in Jacksonville, Florida.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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