Design Quality Engineer
Apply NowCompany: SysMind Tech
Location: Irvine, CA 92620
Description:
Relevant Experience:
5+ years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred with evidence of continued self-development.
Work experience in the Medical Device industry.
Technical/Functional Skills:
GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
Strong creative, analytical and problem-solving skills.
Proficient at interpreting data and putting that data into a report
Proficient at statistical analysis
Experience in EU MDR or other regulatory related projects
Verification and Validation
CAD Support (Preferred Auto CAD and Solidworks)
Experience in creating PFMEAs & Writing reports
Process experience, ability to observe and understand manufacturing processes
Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
5+ years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred with evidence of continued self-development.
Work experience in the Medical Device industry.
Technical/Functional Skills:
GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
Strong creative, analytical and problem-solving skills.
Proficient at interpreting data and putting that data into a report
Proficient at statistical analysis
Experience in EU MDR or other regulatory related projects
Verification and Validation
CAD Support (Preferred Auto CAD and Solidworks)
Experience in creating PFMEAs & Writing reports
Process experience, ability to observe and understand manufacturing processes
Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)