Senior Quality Engineer

Johnson & Johnson • Palm Beach Gardens, FL

2d • Onsite

About The Position

Johnson & Johnson is searching for a Senior Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, 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 Velys Enabling Tech Operation is in need of a Senior 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 Bachelor's degree is required. Degrees in Engineering, Life Science, or related field are preferred.
• A minimum of 2-4 years of related work experience
• Experience working in regulated industries
• Professional quality or Manufacturing Engineering experience.
• 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
• Strong communication, teamwork, problem solving and decision-making skills
• Experience in process quality and validation

Nice To Haves

• Understanding of the NPI (New Product Introduction) process

Responsibilities

• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Addresses and corrects product and process complaints.
• Reports on contract manufacturer performance metrics and ensures management reviews.
• Oversees audits of all quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline.
• Handles complex 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
• Number of Employees: 5,001-10,000 employees