Staff Supplier Design Quality Engineer

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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 . internal employees contact AskGS to be directed to your accommodation resource.

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