Senior Quality Engineer

Senior Quality Engineer

Location:

Irvine, CA

Seniority Level: Mid-Senior level

Employment Type:

Contract

Job Function:
Quality(Void) Assurance

Industry: Pharmaceutical Manufacturing

• Perform Quality Engineering activities related to product development and ongoing cleanroom build support
• Ensure NPD processes comply with quality system and applicable regulatory standards
• Update risk management and design control files and maintain relevant quality documentation
• Develop and execute test method validations and qualification plans
• Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
• Work collaboratively with cross-functional teams including R&D, manufacturing, regulatory, clinical, and marketing
• Perform other duties as assigned by Leadership

• Bachelor's degree in Engineering or Scientific field with 4+ years of experience OR Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience
• Proficient understanding of medical device operations and/or manufacturing processes (medical device experience strongly preferred)
• Relevant Château in product development, quality assurance, and/or related fields
• Knowledge and understanding of Engineering and Quality principles, theories, and concepts
• Understanding of ISO 13485
  
  Experience developing, updating, and maintaining technical content of risk management files
• Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus
• Experience in test method development including validation and/or fixture development
• Solid problem-solving, organizational, analytical, and critical thinking skills
• Strong documentation and communication skills with attention to detail
• Ability to build productive working relationships across all organizational levels
• Ability to manage competing priorities in a fast-paced environment