NPD Quality Engineer

Must Have Technical/Functional Skills

• 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.)

Salary Range $90,year

TCS Employee Benefits

Summary:

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 & amp;
Training Reimbursement. Time Off:
Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance:
Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

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