Job Function: Supply Chain Engineering
Job Sub Function: Quality Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Warsaw, Indiana, United States of America
Job Description:Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
We are searching for the best talent for
Engineer 3, Source Quality, located in
Warsaw, IN.An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.Position Summary:This Engineer 3, Source Quality will use talent to be an individual contributor and lead ad hoc teams. They will collaborate with Procurement, Engineering, R&D, Quality, Operations, and suppliers to implement solutions and improve suppliers' quality, compliance, and overall service/performance.
They will also support and lead initiatives to improve suppliers' performance in order to certify them or reduce receiving inspection activities. Visit and evaluate suppliers through audits or technical assessments. Support the Quality Audit group by providing quality metrics and supplier performance data.
Key Responsibilities:This role, under general direction and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson, procedures and guidelines will:
- Support the incoming inspection group (technician, team lead supervisor, etc.) on the decision-making process and follow-up of material non-nonconformance with suppliers.
- Responsible to coordinate supplier investigations, related to material non-conformances. Participate or lead investigation process and risk analysis of supplier quality excursions.
- Works directly with suppliers and external manufacturers to ensure the products and services received meet requirements and/or specifications.
- Approve and/or advance deviations to product specifications or processes.
- Responsible for generating corrective and preventive actions to suppliers, and verification of the efficacy of such actions for approval and closure
- Support supplier implementation of improvement activities (for example Lean, 6s, SPC, Gage R&R, etc.).
- Collaborate and support the introduction of new products in relation to new components or finished devices provided by suppliers.
- Supports the qualification, validation/certification of supplier's inspection methods and equipment.
- Responsible for the generation and updates to Supplier Quality Agreements.
- Participate with other functional groups and support activities related to changes requested by or to suppliers.
- Responsible to create, review, and approve changes to company procedures, work instructions, forms, inspection reports and other related controlled documentation.
- Attend and participate in quality metric reviews. Responsible for presenting business-related issues or opportunities to next management level.
- Capable of developing junior quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data-driven, risk-based decisions that ensure the quality of the product.
Qualifications/Requirements:- A minimum of a Bachelor's or equivalent university degree is required, with a preferred focus in Engineering or Technical field.
- A minimum of 4 years relevant work experience in the Medical Device or Pharma Industry.
Preferred:- Professional certification - ASQ : CQE, Lean, Six Sigma, Etc.
Other:- This position may require up to 25% domestic travel.
- Candidates must already have authorization to work in the country of employment. This role is eligible for immigration sponsorship, if required. Relocation support is not available for this position.
Required Skills: Preferred Skills:Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy
