Senior Quality Engineer

6267-Auris Health Legal Entity • Santa Clara, CA

7d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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.

Requirements

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

Nice To Haves

• Analytical Reasoning
• Auto-CAD Design
• Business Case Modeling
• Coaching
• Design Thinking
• Mechanical Engineering
• Problem Solving
• Process Oriented
• Product Reliability
• Project Management Methodology (PMM)
• Project Support
• Quality Control Testing
• Research and Development
• Resource Allocation
• SAP Product Lifecycle Management
• Technical Credibility
• Technologically Savvy

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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

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