HireDiversity

Jacksonville, FL, US

Senior Quality Engineer - Night Shift (1 of 4)-3781120831

Description

VISTAKONŽ, a division of Johnson & Johnson Vision Care, is recruiting for a Senior Quality Engineer - Night Shift (1 of 4), to be located in Jacksonville, Florida.

VISTAKONŽ, a division of Johnson & Johnson Vision Care, 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 ACUVUEŽ family of products. Our associates around the world are committed to expanding the ACUVUEŽ brand, and fortifying our position as the worldwide leader in the contact lens industry.

The Senior Quality Engineer ensures quality and validation programs are well-defined, executable, meet customer and business needs, and are in compliance with regulatory requirements. This individual implements global programs/policies/procedures with respect to Validation, Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management. Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA.

The Senior Quality Engineer manages validation projects in support of existing products/processes and propagations of new products at the Jacksonville campus. Project responsibilities will be focused on process improvements, large to multi-site validation projects with process characterization, and DOEs. This position may also oversee qualification activities related to contract repackaging and contract manufacturing projects. Validation responsibilities include, but are not limited to prioritizing and planning all assigned projects for the QA validation department, creating master validation plans and schedules, leading validation project planning, facilitating risk analysis, performing/reviewing failure investigations, documenting & executing qualification protocols and reports, facilitating change validation, supporting raw materials, formulations, and facilities qualifications, supporting/executing DOEs and process characterization studies, developing validation training modules, implementing new or changed quality systems (programs/policies/procedures), and conducting validation and statistics training for Operations, QA, IT, and MSE personnel. Adheres to environmental and safety policies and procedures and supports department's safety and environmental objectives.

This individual develops, enhances, and implements validation programs/policies and procedures for manufacturing equipment/process and computerized (automated) systems, including training programs. Leads validation activities/projects. Creates, reviews and/or approves software, equipment, facilities, formulations, and product/process validation documentation, including site validation master plan. Implements programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management. Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA. Provides consulting, training and guidance on validation principles, risk management, root cause analysis, statistics, and quality systems. Performs other related duties as assigned by management.

Qualifications


A Bachelor's degree and a minimum of 6 years of work experience in Validation/IQ, OQ, PQ/Statistics/Process Engineering/Test Method Development within the Medical Device or other regulated industry is required. A Bachelor's degree in Engineering, Computer Science, or Statistics is preferred. A Master's degree in Engineering, Computer Science, or Statistics is also an asset. CQE certification is preferred. Process Excellence/Six Sigma training or certification is preferred. Medical Device industry experience is preferred. Excellent understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Validation, Commissioning & Qualification, Root Cause Analysis/Failure Investigation, and the QSR/ISO Regulations is required. Excellent communication, interpersonal, conflict management, and organization skills are required. Strong leadership and coaching skills are required. The ability to work in a matrixed organization is required.

This position may require up to 10% international and domestic travel. This position is located in Jacksonville, Florida. To be eligible for this role, you must be able to work a twelve hour (12) rotating shift from 6:00pm to 6:00am, with two (2) weekends required per month. Only individuals who are able to meet this requirement will be considered for this role.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)