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.
#LI-SP1
