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:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

West Chester, Pennsylvania, United States of America

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
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