Senior Quality Assurance Engineer

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson, Vision Jacksonville, FL is recruiting for a Senior Quality Engineer, location in Jacksonville, FL

The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff. The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

Adheres to environmental policy, procedures, and supports department environmental objectives.

Key Responsibilities:

Business Improvements

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

Conduct benchmarking to develop more effective methods for improving quality

Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

Compliance/Regulatory

Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.

Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

New Product/Process Introduction

Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

Supports new product introduction as part of design transfer.

People

Provides mentoring and coaching, for others

Product Quality, Control, and Disposition and Performance Standards

Lead and maintain Material Review Board.

Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality

Product/Process Qualification

Approve IQ, OQ, PQ, TMV or Software Validation

Production/Process Controls

Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.

Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan

Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes

Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

Develop, interpret and implement standard and non-standard sampling plans

Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.

Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Risk Mitigation

Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

Strategic

Ensures effective quality strategies are created for the validation of processes and designs.

Education:

Minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.

Experience and Skills:

• Generally, requires 4-6 years related experience.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
• Demonstrated project management and project leadership abilities are preferred.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.