Senior Quality Engineer
Johnson & Johnson MedTech · Santa Clara, CA · Today
On-siteQuality Assurance$125k–$201k/yrFull-time
About the role
Johnson & Johnson is seeking a Senior Quality Engineer to join our team in Santa Clara, California. This is a fully onsite position.
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 the 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.
- 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.
- Able to work in a fast-paced environment, managing multiple priorities.
- Project leadership experience.
- Must be willing to work in-person at Santa Clara, California, US office location.
Other
- Ability to travel up to 10% domestic and international is required.
- Johnson & Johnson is an Equal Opportunity Employer.
Preferred Skills
- 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.
- Techically Credible.
- Techologically Savvy.
Pay Range
The anticipated base pay range for this position is: $125,000.00 - $201,250.00
Benefits
- For Pay Transparency Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits.