Quality Engineering Leader

Johnson & Johnson•Cincinnati, OH

6d•$109,000 - $174,800

About The Position

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.

Requirements

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

Nice To Haves

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 management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment
Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS)
Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control)

Responsibilities

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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits