Infosoft, Inc. · 20 hours ago
Principal Medical Device Quality Engineer
Irvine, CA
Contract
Onsite
Senior Level, Lead/Staff
$70.30/hr - $70.30/hr
6+ years expInfosoft, Inc. is a global medical device manufacturer focused on innovation and patient care. They are seeking a Principal Medical Device Quality Engineer to lead quality engineering initiatives, manage cross-functional projects, and improve manufacturing processes through innovative solutions.
ConsultingDeliveryHuman ResourcesInformation Technology
Hiring Manager
Riya Singh
Responsibilities
Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations
Manage cross-functional projects, timelines, and budgets; implement digital quality tools ( eQMS , dashboards )
Translate technical information to all levels of the organization through large and small presentations
Independently lead QMS improvement activities and associated projects
Own and perform documentation changes and set policies and standards that are followed by others
Lead CAPA execution, root cause investigations , and quality data analysis to identify trends
Own and drive validation testing (all types), TMV , and software validation testing
Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement
Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk
Drive development and manage execution of complex experiments and tests (including writing and executing protocols ) to validate and improve products and establish robust manufacturing processes; ensure completion of p rocess validations (IQ/OQ/PQ) , analyze results, and develop reports
Qualification
Required
Bachelor's or master's degree in engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences)
6 years of experience in medical device engineering or medical device quality roles
Travel required ~15%
Statistical -based software (Minitab, JMP)
Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports
Proficiency in quality tools (FMEA, CAPA, statistical analysis)
Preferred
Certified Quality Engineer (CQE) or equivalent
Measurement and Test Equipment knowledge and experience are essential
Process Validation experience
Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge)
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
H1B Sponsorship
Infosoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (37)
2023 (10)
2022 (14)
2021 (19)
2020 (23)
Funding
Current Stage
Growth StageCompany data provided by crunchbase