Tata Consultancy Services · 14 hours ago
Senior Quality Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $140K/yrTata Consultancy Services is seeking a Senior Quality Engineer with expertise in Quality Management and compliance regulations. The role involves ensuring adherence to GMP, FDA, and ISO standards while utilizing various quality tools and techniques to oversee regulatory compliance in medical device manufacturing.
Business Information SystemsConsultingInformation TechnologyIT Management
Responsibilities
Knowledge on Quality Management and its tools & techniques
Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
Knowledge on Medical Device Regulatory Standards, MDD and MDR
Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
Knowledge in Statistics, Risk Management and Design control
Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
Experience in creating FMEAs & Writing reports
Experience in PMS (Post Market Surveillance)
Experience in PLM Tool (Windchill preferred)
Good understanding of Design, Drawing and GD&T
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.)
Qualification
Required
Knowledge on Quality Management and its tools & techniques
Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
Knowledge on Medical Device Regulatory Standards, MDD and MDR
Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
Knowledge in Statistics, Risk Management and Design control
Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
Experience in creating FMEAs & Writing reports
Experience in PMS (Post Market Surveillance)
Experience in PLM Tool (Windchill preferred)
Good understanding of Design, Drawing and GD&T
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.)
BACHELOR OF COMPUTER SCIENCE
Preferred
Experience in PLM Tool (Windchill preferred)
Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
Benefits
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Company
Tata Consultancy Services
Tata Consultancy Services is a business solutions company that specializes on information technology services and consulting.
Founded in 1968
10001+ employees
H1B Sponsorship
Tata Consultancy Services 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 (7880)
2024 (9690)
2023 (8537)
2022 (11159)
2021 (9813)
2020 (11984)
Funding
Current Stage
Public CompanyTotal Funding
unknown2004-08-25IPO
Leadership Team
K. Krithivasan
Chief Executive Officer & Managing Director
Aarthi Subramanian
President and Chief Operating Officer
Recent News
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2026-01-16
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2026-01-16
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