Staff Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

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 companys 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.

Staff Quality Engineer Duties

• 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

Required Experience and Skills:

• 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 Experience & Skills:

• 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)

Other:

• This position is located in Cincinnati OH and has up to 10% of both domestic and international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Bioinformatics Biological Engineering Biostatistics Coaching Critical Thinking Design of Experiments (DOE) Healthcare Trends Industry Analysis Innovation Medicines and Device Development and Regulation Product Development Relationship Building Research and Development Researching SAP Product Lifecycle Management Standard Scientific Processes and Procedures Technologically Savvy

The anticipated base pay range for this position is :

$91000-$147200 USD$

Additional Description for Pay Transparency:

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 Companys 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 Additional information can be found through the link below. Experience:

Staff IC