Job Function:
Supply Chain Engineering
Job Sub Function:
Quality Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Palm Beach Gardens, Florida, 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.
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a
Sr. Supplier Quality Engineer to be located in
Palm Beach Gardens, FL.
The Sr. Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of DePuy Synthes products.
Works collaboratively with management to drive decisions regarding Quality Engineering methods to produce leading-edge customer-tailored engineering final deliverables.
Key Responsibilities:
- Implement SQ strategy and follow Supplier Quality standards
- Manage supplier related Non-Conformities (NC/ SCAR) and Corrective and Preventive Actions (CAPA)
- Oversee supplier change requests (SCR)
- Support Process Validations at suppliers
- Support QE with supplier product PVE's (First Article Inspection, Control Plans, Critical to Quality, Capability studies)
- Contribute to product investigations related to product and process complaints.
- Provide Supplier Quality Engineering support for PLM changes.
- Support supplier preparation for inspections by authorities / third parties
- Support Procurement executing supplier transfer projects
- Support for Quality Agreement and Change Agreements, supplier assessments and supplier audit process
- Report on supplier performance metrics and management reviews.
- Lead or participate in Quality projects: Legacy review, remediation, integration
- Implementation of improved/new standards for supplier quality
- 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.
- 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
- May directly or indirectly supervise and/or provide directions to other Supplier Quality Engineers.
- Collaborate with other functional departments such as Quality, Engineering, R&D, Regulatory and Sourcing
- May interact with government agencies such as the FDA, Regulatory Agencies such as Notified Bodies and will interact with suppliers providing products and services that could impact the quality of J&J products
- Performs other duties assigned as needed
Qualifications
Education:
- Bachelor's or equivalent university degree is required; A concentration in Engineering, Life Science, or related field is preferred
Experience and Skills:
Required:
- A minimum of 2-4 years of experience in a GMP and/or ISO regulated industry
- Strong communication, teamwork, and problem-solving skills
- Strong root cause analysis skills
- Ability to work in stressful/fast-paced environment
- Ability to work and interact with co-workers to accomplish company goals in a team environment
- Analytical/Problem Solving Skills
- Ability to communicate verbally and in writing
- Ability to learn
Preferred:
- Experience in the medical device and/or pharmaceutical industry
- FDA and ISO regulations knowledge
- Experience or knowledge with machining manufacturing processes, injection molding, robotics, electronics and/or software
- Operations supplier quality experience
- FDA CFR Part 820 and/or ISO 13485 knowledge
- Auditing background
- Management skills
Other:
- Fluency (oral & written) in English is required
- Up to 10% travel may be required
- Six Sigma, Lean, or ASQ Certification and professional licenses preferred
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
