Senior Quality Engineer NPD

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

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

The Senior Quality Engineer plans coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products design verification tests process validations and quality processes to ensure compliance with the companys Quality System policies and procedures and applicable external requirements and standards. As needed assists to develop quality-engineered systems and products and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other engineers. A few of the responsibilities may involve collaborating with other members of the Design Team. Will contribute to activities including risk management document development creation and design of catheter test methods authoring of test protocols and testing of products during their development cycle.

SECTION 2: DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Working with other functional groups including R&D and Operations in support of new product development engineering projects quality assurance activities and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development transfer and maintenance of products/processes throughout the product lifecycle.
• Oversight from a Quality NPD perspective of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans AFMEA DFMEA and PFMEA.
• Write review and/or approve process and product validation protocols and reports equipment qualifications engineering change orders.
• Use statistical tools to analyze data make acceptance decisions and improve process capability (Six Sigma Statistical Process Control (SPC) Design of Experiments (DOE) etc.). Performs statistical analysis of data generated including but not limited to: Gauge R&R ANOVA Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Ensure that development activities follow design control requirements (Design Trace Matrix) product is tested per applicable standards GSPR are met per the MDR and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving failure analysis and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Recommend issue resolution to management for significant capability and compliance issues.
• Works closely with functional leadership in planning and executing project milestones.
• Plans develops coordinates and directs one or more large important engineering projects or a number of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Assesses the feasibility and soundness of proposed engineering evaluation tests products or equipment when necessary data are insufficient or confirmation by testing is advisable.

Additional Duties:

• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
• 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

SECTION 3: EXPERIENCE AND EDUCATION*

• Bachelors degree required; preferably in engineering and/or scientific discipline
• Or a minimum of 4 years of quality manufacturing or research and development experience in a medical device or other regulated industry

SECTION 4: REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Ability to define problems collect and analyze data establish facts and draw conclusions and recommendations

• Ability to use broad knowledge of regulatory technical and business requirements to conduct due diligence assessments
• Ability to apply project management skills to ensure fulfillment of new product development requirements
• Ability to develop and implement Quality standards
• Demonstrated auditing and problem-solving skills
• Knowledge of leading-edge Quality Engineering design control and verification and validation (V&V) tools and methodologies
• Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE DMAIC and ANOVA.
• Six Sigma/ Design for Six Sigma experience and/or knowledge of Process Excellence tools
• Lean manufacturing experience
• Knowledge of Quality and operations systems and processes including GMP
• Working knowledge of CAD software (Solidworks AutoCAD) Working knowledge of SolidWorks other CAD based programs (i.e.. basic dimensioning tolerance stack analysis) is a plus.
• Experience with Minitab R and other statistical software is a plus.
• Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.

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The anticipated base pay range for this position is :

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Senior IC