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:DePuy Synthes is recruiting for a Senior Quality Engineer, located in Palm Beach Gardens, FL.
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 provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. For more information, visit www.depuysynthes.com.
As a Senior Quality Engineer, you will support the rapidly growing Velys Enabling Tech Operation, providing overall quality assurance leadership of on-site manufacturing areas. This position is focused on the support of New Product Introduction and Continuous Improvement projects at the Palm Beach Gardens site.
If you have a passion for innovative products and want to work on exciting projects in a multidisciplinary environment that helps people live better, this is the job you've been searching for!
Key Responsibilities:- Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP) and international organization for standardization (ISO).
- Collaborate with cross-functional team to ensure smooth transfer of new products into manufacturing.
- Provide product team support for quality system design, audit, and compliance assessments.
• Audit and approve manufacturing, quality, engineering, and validation documents for conformance to business practices and departmental procedures.
- Develop standard operating procedures, specifications, and provide technical transfer and validation support.
- Provide data and documentation in support of the development of validation strategies.
• Provide sampling plans and approve inspection methods for evaluation and testing of components and products.
- Create and execute test method validations for test fixtures and gages.
- Implement, monitor, and report out on process performance metrics to ensure effectiveness of quality systems to identify, correct, and prevent defects.
QualificationsEducation:- B.S. degree in Engineering or related technical field is required.
Experience and Skills:Required:- 3+ years of related experience (or equivalent with advanced degree) is required.
- Experience working in regulated industries.
- Relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards).
- Experience and a proven track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean, and Six Sigma Methodologies including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Demonstrated project management and project leadership abilities.
- Strong communication, teamwork, problem solving, and decision-making skills.
Preferred:- 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.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
Other:- This position will require less than 10% travel.
#LI-Hybrid
Required Skills: Preferred Skills: 
