Tata Consultancy Services · 4 days ago
NPD Quality Engineer
Plymouth, MN
Full-time
Onsite
Mid Level
$90K/yr - $95K/yrTata Consultancy Services is looking for an NPD Quality Engineer to ensure compliance with quality management standards and regulatory requirements in the medical device industry. The role involves knowledge of quality management tools, regulatory standards, and effective communication skills to support project management and documentation processes.
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 on Validation process, writing protocols/ reports
Very good understanding/ experience in writing procedures, product specs and work instructions
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)
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 on Validation process, writing protocols/ reports
Very good understanding/ experience in writing procedures, product specs and work instructions
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)
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
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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