Johnson & Johnson's Ethicon Endo-Surgery is seeking a Senior Supplier Quality Engineer to support and lead Quality Engineering activities in New Product Development and ongoing manufacturing, focusing on resolving non-conformances, CAPA, and improving quality systems and processes.
Requirements
- Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications
- Analytical and creative thinking abilities
- Project management skills to handle multiple initiatives concurrently
- Problem-solving and prioritization capabilities
- Strong organizational skills and ability to synthesize information from diverse sources
- Rapid comprehension of complex concepts
- Continuous research and ongoing learning of industry trends and regulatory requirements
Responsibilities
- Provide leadership in design & implementation of world-class quality Engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products.
- Activities include driving correction, corrective action, prevention, detection of defects at the earliest phase of product design, continuous improvement & customer satisfaction.
- Provide leadership and technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
- Provide review and approvals for the release of new products ensuring quality requirements are met.
- Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking.
- Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers.
- Responsible for following and administering safety.
Other
- A Bachelor or equivalent degree in Engineering or applicable sciences is required. Other Bachelor/Master degrees acceptable with applicable work experience in a regulated industry. Electrical Engineering Degree preferred.
- 2-4 years of related work experience
- Strong communication skills (written and verbal)
- Negotiation and influencing skills
- Effective assertiveness and quality assurance
