Johnson & Johnson MedTech · 1 day ago
Staff Quality Engineer
Cincinnati, OH
Full-time
Onsite
Senior Level, Lead/Staff
$91K/yr - $147K/yr
6+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes through innovative solutions. The Staff Quality Engineer will support New Product Development and Lifecycle Engineering, ensuring compliance and quality standards while leading engineering initiatives to enhance product design and manufacturing processes.
Hospital & Health Care
Responsibilities
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
Researches and compiles worldwide regulatory and technical standards for shift in design related quality trends
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 world with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction
Provides support to Johnson and Johnson process excellence initiatives including six sigma, design excellence, and lean thinking
Oversees engineering operations, scientific evaluations of new products, technology concepts and development
Purchases or designs equipment that meets health, safety and environmental standards set by the company
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
Researches and reports on competitors' design strengths and weaknesses
Provides technical expertise across a broad range of engineering areas and methodologies
Leads and oversees the activities of engineers and support staff
Responsible for communicating business related issues or opportunities to next management level
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if 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
May support technical training (i.e. statistics and quality methods) and teaching/mentoring of other
Qualification
Required
A minimum of 6 years of 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 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)
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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