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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