Senior Quality Engineer

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson is recruiting for a Senior Quality Engineer, located in Santa Clara, California. This is a fully onsite position.

Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’ skills.

Key Responsibilities:

• Support product requirements, risk management, verification strategies, validation strategies, and quality audits.
• Collaborate on, review, and approve design, manufacturing, quality, engineering, and validation / qualification documentation.
• Collaborate cross-functionally with, including but not limited to, Quality, R&D, Supply Chain (including Manufacturing), Regulatory Affairs, Marketing, Clinical Affairs/Research.
• Develop, revise, and apply quality system procedures.
• Drive prevention and detection of defects at earliest phase of product design, continuous improvement, and customer satisfaction.
• Investigate and resolve product and quality system nonconformances.
• Provide recommendations on statistical analysis and analytical problem solving for product development.
• Lead and execute design and quality projects.
• Ensure compliance with GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and other applicable standards and regulations.
• Guide junior quality engineers.

Qualifications

Education:

• Bachelor’s or equivalent university degree in Engineering or relevant science field is required.

Experience and Skills:

Required:

• Minimum of 4 years of related work experience in medical device industry or other highly regulated industry
• Experience with electrical-mechanical systems
• Experience with standards and regulations such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, 21 CFR 820
• Experience in design and development, risk management, statistics, product inspection, technical writing
• Experience in working within and across teams
• Effective communication skills with different levels of management and organizations
• Ability to work in a fast-paced environment, managing multiple priorities
• Project leadership experience
• Must be willing work in-person at Santa Clara, California, US office location

Other:

• Ability to travel up to 10% domestic and international is required