Staff Supplier Design Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is currently recruiting for a Staff Supplier Design Quality Engineer! This position will be located in West Chester, PA.

Position Summary:

The Staff Supplier/Source Design Quality Engineer supports new product development and design transfer activities by ensuring Supplier and Strategic Collaborator processes meet quality, regulatory, and TECA business requirements. This role leads process and test method validation, risk analysis (i.e. PFMEA), supplier qualification, and inspection planning, while applying statistical and quality engineering tools to decision-making. The position also provides quality system leadership across areas such as CAPA, nonconforming materials, complaints, inspections, and risk management, and works cross-functionally with R&D, Quality, Regulatory, Supply Chain, and Supplier/Strategic Collaborator to ensure compliance and successful product realization.

Key Responsibilities:

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

• Supports transfer to manufacturing activities both in Product Development and base business.
• Conduct and lead process verification and validation activities at the supplier/collaborator.
• Conduct and lead design / process failure mode effects and analysis.
• Develop inspection methodology and acceptance criteria for inspection sample plans.
• Provides leadership in Test Method Validation (TMV) at the supplier/collaborator
• Works closely with suppliers on the qualification of new parts and processes supporting product development.
• Applies statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Supports Gage R&R studies.
• Conduct assessments of new suppliers as part of the project teams.
• Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Post Market Surveillance, Nonconforming Materials, Risk Management, internal and external Inspections, etc.
• Provides leadership in the understanding of medical device regulations to other disciplines. This candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Supplier and Source Quality, Manufacturing, and Marketing.
• 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

Qualifications

Education:

A minimum BS degree in a mechanical engineering or related technical discipline with a minimum of 6-8 years of experience in related field is required.

Quality Engineering Certifications are a plus (e.g. ASQ CQE, PMI PMP, 6-Sigma, etc.).

Experience:

• 4-6 years of related experience is required
• Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred
• Training experience (Train the Trainer) internally and externally is strongly recommended.
• Experience working in both an FDA and European regulatory environment is required.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• A thorough understanding of GMP/ISO/Validation regulations (FDA 21 CFR 820 QSR, ISO 13485).
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is required.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Interpersonal skills / characteristics:

• Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
• This candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals.
• Quality-oriented mindset
• Communication skills
• Independency
• Integrity
• Able to communicate and writing skills in English (preferred)
• Flexibility
• Service minded

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 https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: