Sr Engineer Quality Engineering

Johnson & Johnson Johnson & Johnson · Pharma · Milpitas, CA +2

This role is for a Sr. Engineer Quality Engineering in the medical device industry, focusing on ensuring new and existing medical devices meet their intended use. Responsibilities include providing quality and technical leadership, establishing and meeting Critical to Quality (CTQ) attributes, leading design control strategy, collaborating with functional partners, and managing risk management activities. The role requires a Bachelor's degree in Engineering or a related technical field, 4 years of experience in a regulated industry, and practical understanding of QSR/ISO medical device regulations.

What you'd actually do

  1. Quality leadership on product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
  2. Ensures effective risk management or product harms and hazards and improves capability of processes.
  3. Leads development team in design control strategy and implementation
  4. Collaborates with functional business partners to proactively address quality issues during new product development, design changes and product verification/validation.
  5. Leads activities associated with risk management and human factors. This includes working with engineers and product development to identify areas of high risk within their processes; establishing, monitoring and implementing risk mitigation plans; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.

Skills

Required

  • Bachelors or equivalent university degree in Engineering or other related technical field
  • 4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry
  • Strong communication, interpersonal and organizational skills
  • Practical understanding of QSR/ISO medical device regulations especially design controls, and risk management
  • Ability to function in a team environment and deliver on team objectives
  • Strong attention to detail
  • Strong written and verbal communication skills
  • Developed presentation skills

Nice to have

  • Experience in Medical Device industry
  • Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices
  • Human Factors Engineering experience

What the JD emphasized

  • 4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry.
  • Practical understanding of QSR/ISO medical device regulations especially design controls, and risk management.