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 https: //www.jnj.com

Job Function:

R& D Product Development

Job Sub Function:

R& D Mechanical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

San Jose, California, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a Sr. Quality Engineer, located in Santa Clara, California. This is a fully onsite 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 https: //www.jnj.com/.

Our Design and Sustaining Quality 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 contractor personnel in achieving deliverables.

Qualifications

Education:

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

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
• Knowledge of 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, USA office location

Preferred:

• Proficiency in use of data visualization software, e.g., Power BI, Tableau
• ASQ Certified Quality Engineer certification
• ASQ Certified Reliability Engineer certification
• Green Belt certification in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)

Other:

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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$91, 000-$147, 200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation – up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.