Staff Quality Engineer

Johnson & Johnson•Cincinnati, OH

30d•Onsite

About The Position

Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. Position Summary: This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis and provides input or approval for detailed design specifications, tooling, fabrication, and testing. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc.

Requirements

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)

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

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

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
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 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

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