Must Have Technical/Functional Skills
- Support all phases of Operations MDD/MDR product MDD/MDRTF remediation.
- Operations Supplier (CM/OEM) and continuity engineering tasks
- Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
- Review of inspection and test requirements within production plans requiring remediation
- Initiate corrective action of problems and deficiencies to ensure process and/or product quality as required
- Tech File review
- Need help supporting NCMRs, Paper IFUs (versioning capital, IFU kits MATNRs), PCRs, PCHs, Work Instructions Updates, CAPAS/Corrective Actions from NCMRs, PPAP, providing manufacturing technical support to SQEs, Supplier Process Improvement, Reporting (Pareto NCMRs, trending and insights/Help needed), PCR - Product EOL PCR, Product replacement PCR.
Roles & Responsibilities
- Control plan review, Inspection Criteria creation, QAC Creation, ECO & SMECO Approval, DCO routing
- Driving supplier quality performance, including new product development and product quality improvement.
- Qualifies suppliers according to Supplier standards (PPAP- Production Part Approval Process) and may administer a Certified Supplier Program in receiving inspection
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
- Works with supplier to obtain each deliverable according to the PPAP procedure and evaluate adequacy to the requirements
- PFMEA, Process controls, MSA, Supplier Validation (IQ/OQ/PQ), Process Capability
- Providing leadership and management for the supplier quality department.
- Overseeing supplier quality team and establishing quality control objectives
- Work with R&D and Contract Manufacturer to create Bill of Materials (BOM)
- Work with R&D and Contract Manufacturer to create subcomponent specifications
- Create Risk documents for subcomponents
- Create Test Method Validations (TMV)
- Qualify/validate subcomponents
- Implement Acceptance Activities for subcomponents
- Implement Quality Agreements
- Collaboration with different functions, Supplier communication
- Understand qualification requirement/process, knowledge of quality agreements
Salary Range: $80,000 - $100,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comp rehensive 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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