Quality Engineer, DePuy Synthes

Johnson & Johnson • Palm Beach Gardens, FL

9d • Onsite

About The Position

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 Velys Enabling Tech Operation is in need of a Quality Engineer who provides overall quality assurance leadership of on-site manufacturing areas. 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 New Product Introduction and Value Improvement projects implementation to the PBG Site.

Requirements

• A minimum of a Bachelor’s degree is required.
• A minimum of 1-2 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)

Nice To Haves

• Degrees in Engineering, Life Science, or related field is preferred.
• Experience and a proven track record of implementing appropriate risk mitigation
• Advanced knowledge of Six Sigma methodologies.
• Understanding of the NPI (New Product Introduction) process

Responsibilities

• Provides comprehensive quality support for daily manufacturing 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.
• Evaluates contract manufacturer 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.
• Facilitates technical issues for manufacturing processes that are to be transferred to satellite facilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level