Senior Quality Engineer (MedTech)

Location: Palm Beach Gardens, Florida, United States of America; onsite

Company

Johnson & Johnson MedTech develops medical devices, surgical technologies, orthopedic solutions, and interventional products.

What you will do

• Lead quality assurance for onsite manufacturing areas and support steady-state manufacturing processes.
• Support quality system design, audits, compliance assessments, and product team activities.
• Apply GMP, EES, ISO, and other process excellence standards in daily quality operations.
• Address product and process complaints and implement corrective actions.
• Monitor contract manufacturer performance metrics and support management reviews.
• Oversee quality system audits, measurement systems, defect prevention, and technical issue resolution for process transfers to satellite facilities.

Requirements

• Bachelor’s degree required; engineering, life science, or a related field preferred.
• 2–4 years of related professional experience in a regulated industry.
• Professional quality engineering or manufacturing engineering experience.
• In-depth knowledge of product and process risk management, MDSAP, MDD, MDR, FDA, and ISO standards.
• Proven experience implementing risk mitigation, process quality, and validation activities.
• Strong communication, teamwork, problem-solving, and decision-making skills.

Nice to have

• Understanding of the New Product Introduction process.
• Experience with GAMP, lean supply chain management, process improvement, quality control, and quality systems documentation.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo.
• Full-time employment with Johnson & Johnson MedTech, with a planned transition to DePuy Synthes employment processes following the orthopaedics separation.
• Less than 10% travel required.
• Equal opportunity employment and an inclusive interview process with accommodation support.