Staff Quality Engineer NPD

Johnson & Johnson Innovative Medicine; Irvine (CA); On-site; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Irvine, CA seeks a Staff Quality Engineer to lead QA activities across the product lifecycle, support NPD teams, develop quality systems, and drive compliant solutions in a complex medical device environment.

You will mentor engineers, apply Six Sigma, DFMEA, PFMEA, and DOE methods, and collaborate with R&D and Operations to ensure product quality while meeting regulatory standards.

Qualifications

• Bachelor’s degree in engineering or science.
• Minimum 6 years in quality, manufacturing, or R&D in medical devices.
• Six Sigma or Design for Six Sigma experience.
• Lean manufacturing experience.
• Auditing and problem-solving skills.

Responsibilities

• Lead quality assurance activities across the product lifecycle.
• Collaborate with R&D and Operations on new product development.
• Apply quality tools to develop, transfer, and maintain products/processes.
• Develop risk management plans and design controls.
• Write and review validation protocols and reports.

Skills

Problem solving

Data analysis

Leadership

Communication

Education

Bachelor’s degree

Master’s degree preferred

Tools

SolidWorks

AutoCAD

Minitab

R

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com

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.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

The Staff Quality Engineer – Leads, plans, supervises, and coordinates 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 company’s 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 leading a team of Quality Engineers and 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 practicesfor the effective and efficient development, transfer, and maintenance of products/processesthroughout the product lifecycle.
• Leading efforts with quality improvement opportunities as appropriate to legacy products,continuous improvement and customer satisfaction.
• 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 processcapability (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.
• Support sterility, biocompatibility and packaging test requirements following company standard operation procedures for new products.
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested perapplicable standards, GSPR are met per the MDR, and product isproperly 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 theorganization in conferences to resolve important questions and to plan and coordinate work.
• Recommend issue resolution to management for significant capability and complianceissues.
• Works closely with functional leadership in planning and executing project milestones.
• Plans, develops, coordinates, and directs one or more large important engineering projects or anumber of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improvedtechniques or procedures.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products orequipment 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

• Bachelor’s degree, required; preferably in engineering and/or scientific discipline
• Master’s degree is preferred
• A minimum of 6 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.
• Ability to lead and mentor a diverse array of employees at all levels of the organization
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.
• Prior people leadership/management skills.
• 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 (ie. 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.

Required Skills:

Preferred Skills:

Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

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)).

This position is eligible to participate in the Company’s long-term incentive program.

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