Ecocareers ยท 1 day ago
Sr. Quality Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
4+ years expEcocareers is a company focused on quality engineering in the medical device industry, and they are seeking a Senior Quality Engineer. The role involves ensuring compliance with quality systems, developing test methods, and collaborating with cross-functional teams to facilitate product development and validation activities.
Staffing & Recruiting
Responsibilities
Perform Quality Engineering activities related to product development and ongoing cleanroom build support
Ensure NPD processes comply to quality system and applicable regulatory standards
Update risk management and design control files. Maintain relevant quality documentation
Develop and execute test methods 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
Other duties assigned by Leadership
Qualification
Required
Proficient understanding of medical device operations and/or manufacturing processes
Relevant experience 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 in test method development including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills
Bachelor's degree in engineering or Scientific field & 4+ years' experience -OR- Master's Degree
Equivalent in Engineering or Scientific field & 3+ years' experience
Good documentation and communication (e.g., written and verbal) skills with keen attention to detail
Ability to build productive working relationships and interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Preferred
Medical Device experience strongly preferred
Experience using statistical software (i.e. Minitab) a plus
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase