Vistakon, Johnson & Johnson Vision Care, Inc.(JJVC), a member of Johnson & Johnson's Family of Companies is recruiting for a Staff Quality Engineer to be located in Jacksonville, FL.
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.
This position will be responsible for the continuing leadership and support of the site administration and management of quality systems such as Management Review, Global Change Control, Global Application Change Control, and Corrective Actions/Preventive Actions (CAPA). This position will ensure the Quality Systems are well-defined, executable, meet customer and business needs, and are in compliance with regulatory requirements. This will include analysis and input into validation, risk assessment, and failure investigations to align with our world class compliance goals.
Leads and/or contributes to the site management reviews, business unit reviews, and other quality system related reviews; which includes proactively examining the system to identify areas for review, change, or elimination. Responsible for generation and analysis of data for reviews, and the presentation of the information in review forums.
Leads and/or contributes to the activities surrounding CAPA, including investigation activities, immediate corrections, corrective actions, and preventive actions. Leads and/or contributes to root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.
Leads and/or contributes to the Global Change Control and Global Application Change Control program including ensuring the change request program is well-defined, executable, meeting customer and business needs, and in compliance with regulatory, sector, and franchise requirements.
Proactively identifies and leads the streamlining and standardization of Johnson & Johnson VisionCare, Inc. (JJVC) quality systems, including but not limited to change management, Nonconformance, CAPA, management reviews. Develops, plans, and conducts projects with moderate to high technical responsibility, complexity, or strategic input.
Responsible for analyzing and monitoring efficiency and effectiveness of metrics associated with above mentioned quality systems. Demonstrates strong proficiency in applying established tools and methods (for example Six Sigma, Lean, process capability, and statistical process control) to identify and realize process and business improvements. Mentors others in various technical capabilities.
Proactively examines and leads improvement to systems, processes, and standards to identify areas for review, change, or elimination. Also ensures programs are well defined, executable, meet customer and business needs, and are in compliance with regulatory requirements. Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.
- Lead and Administer quality systems, which could include Global Change Control/Global Application Change Control, CAPA, NC Analysis, and/or Management Review. (40%)
- CAPA: Lead the site CAPA system ensuring all records are compliant, timely, and effective. Liaison between Operations, Engineering, and Quality Assurance for the completion and closure of CAPAs. Follow-up with applicable departments to ensure compliant and timely completion of CAPA activities.
- Change Control: Lead the site Change Control systems ensuring all records (CRs) are compliant, timely, and effective. Liaison between Operations, Engineering, and Quality Assurance for the completion and closure of CRs. Follow-up with applicable departments to ensure compliant and timely completion of CR activities.
- Management Review and NC Analysis. Lead NC Analysis and Management Review process for business and site levels; including tracking and trending of quality performance metrics, identify improvement opportunities, and follow up on action items.
- Develops, analyzes, reports and acts on quality systems data, looking for trends and lead review process with management.
- Plan, lead, and conduct the streamlining and standardization of JJVC quality systems. Establishes, analyzes, and continuously leads efforts to improve linkages of quality systems including: Nonconformance’s (NC), Root Cause Investigations (RCI), Corrective Actions/Preventive Actions (CAPA), Change Control, business unit and site management reviews, Validation, and Risk Management.
- Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Provides input into Quality System programs and revise and improve procedures and processes including but not limited to: change management, NC, RCI, CAPA and failure investigation processes.
- Participates in technical reviews and prepares for and participates in inspections with respect to the Quality Systems.
- Establish and lead improvement in training programs to train business partners on quality system platforms. Mentor others in various technical capabilities.
- Perform other related duties as assigned by management, such as the support and streamlining/standardization of other Quality Systems.
- Bachelor’s Degree (or equivalent) in Engineering, Computer Science, Chemistry, or related field AND 6 or more years related experience.
- A minimum of six (6) years of professional experience working in the Manufacturing, Engineering, Quality Assurance or Regulatory Affairs/ Regulated industries is required.
- An in-depth knowledge of FDA/ISO requirements, with specific focus on Change Management and CAPA, and quality and operations systems and processes is required
- Advanced knowledge of Quality Engineering / Scientific Method techniques and principles are preferred
- Strong technical understanding of manufacturing equipment and processes is preferred.
- Understanding of new product introduction processes, and expertise in process qualification/validations is preferred.
- Understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Validation, Commissioning & Qualification is preferred
- Root Cause Analysis/Failure Investigation is required
- Experience managing projects and demonstrating project leadership abilities is preferred.
- There might be 20% travel required for this role.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Johnson & Johnson Vision Care, Inc. (6094)