Johnson & Johnson is recruiting for a Staff Quality Engineer, located in Santa Clara, California, USA. 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

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 personnel in achieving their responsibilities.

Qualifications

Education:

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

Experience and Skills:

Required:

• Minimum of 6 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

• Ability to work with minimal supervision

• 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

• The anticipated base pay range for this position is $100,000 to $172,500. In California Bay Area, the anticipated base pay range for this position is $114,000 to $197,800.

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:

• Vacation – up to 120 hours per calendar year

• 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

• 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.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.