Quality Engineering Leader

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

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati, Ohio, United States of America

Job Description:

Ethicon (Johnson & Johnson) is currently recruiting for a Quality Engineering Leader. This position will be located in Cincinnati, Ohio.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines:

• The candidate will oversee both Harmonic and Advanced Bipolar divisions within lifecycle and have 3-5 direct reports.
• Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives.
• Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development.
• Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization.
• Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems.
• Oversees the implementation of changes with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction.
• Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes.
• Assures compliance with all local government and company regulations, policies and procedures.
• Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests.
• Research and report on competitors' design strengths and weaknesses.
• Provides technical expertise across a broad range of engineering areas and methodologies.

Qualifications

Education:

• Bachelors degree or equivalent in Science, Engineering, Technology or Math is required; Masters degree or equivalent is preferred

Experience and Skills:

Required:

• A minimum of 6 years of related work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience
• Advanced knowledge of Quality Engineering/Scientific methods and techniques
• Applied statistics of growing complexity
• Test method development, statistics, and reliability
• Experience working within a team, acquiring feedback, negotiating, and training
• Understand new concepts quickly, research and maintain ongoing learning of industry regulations
• Fundamental technical understanding of manufacturing equipment and processes
• Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics)

Preferred:

• Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications
• An ASQ certification (CQE, CQM, CRE or CQA)
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification
• Project