Calibration, Change Management, Cross-Functional, Data Description Language (DDL), ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Healthcare Quality, Industrial Engineering, Leadership, Legal, Loan Funding, Manufacturing Engineering, Medical Equipment, Network Routers, Operations Management, Process Manufacturing, Process Sheet, Product Lifecycle Management, SAP, Student Loans, System Operations, Team Lead/Manager, Windchill PLM Software
Must Have Technical/Functional Skills
- A degree level or similar qualification in mechanical or industrial or packaging engineering.
- Minimum 5 years of hands-on experience in medical device quality systems in various operational tasks of quality systems
- Knowledgeable in medical device FDA, MDD and MDR GMP requirements.
- Experience leading cross-functional teams is required
- Change management in regulated operational environments is preferred (ERP & PLM systems)
Roles & Responsibilities
- Support Packaging department and finalize validation activities
- DDL function for Windchill/SAP tasks
- Updating Packaging work instructions
- Create/Update Process sheets/inspection sheets
- Participate in Pack /Label and MD systems deployment and be trained on new system to be able to support day-to-day activities
- Safety upgrade, validation and calibration
- ERP change tasks
- Tool crib consumables inload in windchill - partner with vendors
- Windchill FIA support
- Workflow /Router updates in SAP
- Process/manufacturing engineering support
- Process training support
Salary Range: $90,000- $95,000 a 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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Tata Consultancy Services Ltd