Johnson & Johnson Vision Care a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Quality Engineer! This position is located in Jacksonville, FL.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Senior Quality Engineer applies comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. The incumbent will 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

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.

People

Provides mentoring and coaching, for others.

Product Quality, Control, and Disposition and Performance Standards

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

Qualifications

Education:

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

Required:

• 4-6 years years industry experience working in medical device and/or pharmaceutical manufacturing, Quality Assurance or Regulatory fields.

• In depth understanding and application of principles, concepts and practices of production manufacturing, sterilization, and Quality Assurance procedures.



• Thorough knowledge of ISO/FDA regulatory requirements

• Excellent organizational, interpersonal, written, and oral communication skills.

• Root cause analysis experience required. Ability to recognize and resolve technical issues.

• Ability to organize and analyze data.

• Strong knowledge of software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

Preferred:

• The ability to perform "hands on" troubleshooting and problem solving. The ability to think on the feet and providing sound judgment.

• Good technical understanding of manufacturing equipment and processes.

Other:

• This position has rotating shifts from 6pm-6am, shift differential is available.

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