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Job Description:

You will be responsible for:

Under the direction of Quality Engineering and/or Quality Operations leadership, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

New Product / Process Introduction

• Support new product introduction as part of design transfer.

• Support planning and execution of manufacturing process qualification including IQ, OQ, PQ, Process Verification and Test Method Validation (TMV)
• Ensure that all critical to quality (CTQ) features are identified and adequately addressed in control plan by qualified test methods
• Lead risk management activities and develop process FMEAs to ensure that process risk has been fully assessed, appropriate risk controls implemented, and risk reduced as far as possible

Product Quality, Control & Disposition and Performance Standards

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

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.

Other:

• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications / Requirements:

• A Bachelor’s Degree, preferably in engineering: Mechanical, Electrical, Industrial or applicable science.
• Master or Doctorate in applicable sciences, preferable.
• 4 years experience as a Quality Professional in the Medical Device Industry required.
• Demonstrated knowledge of manufacturing principles and practices, and procedures

Skills:

Required:

• Excellent communication skills in English, spoken and written.

• Ability to perform “active involvement” in the solution of problems and resolution of problems, preferably. Capacity to solve problems providing good judgment is highly desired.
• Experience conducting Process Verification / Validation
• Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis
• Interpersonal skills that foster collaboration as it relates to technical situations
• Strong initiative and follow-through in completing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or leadership experience

Preferred:

• Experience with inspection & test methods including GD& T
• Experience working with ERP systems and associated Quality process flows
• Strong experience with Six Sigma or Lean
• Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus