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:We are searching for the best talent for Senior Quality Engineer to join our DePuy Synthes Quality organization at our two locations in West Palm Beach (WPB) and Palm Beach Gardens (PBG), FL.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Our rapidly growing DePuy-Synthes Power Tools and Velys Enabling Technology Operation is in need of a Sr Quality Engineer who provides overall quality assurance leadership of on-site manufacturing, packaging, labelling and finished goods control processes. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. This position is focused on the support of current manufacturing operations, GMP compliance and Value Improvement projects implementation to the PBG and WPB Sites.
Key Responsibilities
- Provides comprehensive quality support for daily manufacturing, inspection and testing activity.
- Manages the initiation, containment, investigation, disposition and closure of Non-Conformances in the PBG and WPB MAKE Sites.
- Performs and/or supports CAPA records, including risk assessment, root cause investigation, corrective and preventive actions and effectiveness monitoring.
- Utilizes industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
- Addresses or escalates product and process complaints.
- Monitor, report and evaluate performance metrics and supports management reviews.
- Conducts audits of all quality system categories to assess compliance to process excellence standards.
- Implements comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to man.
- Provides leadership in Quality Systems compliance and applies quality control tools and techniques to ensure continuous improvements and effective implementation of CAPA.
Qualifications
Education:
- A minimum of a bachelor's degree is required. Degrees in Engineering, Life Science, or related field is preferred.
Experience and Skills:
Required:
- A minimum of 3 - 5 years of relevant work experience or internships.
- Experience working in regulated industries
- This position will require 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
Preferred:
- Advanced knowledge of Six Sigma methodologies.
- Understanding of the change controls and risk management processes.
Other:
- This position will require less than 10% travel
- Full-time role and able to split time between two locations in Palm Beach County 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.
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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 (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy
