Job description

Job Details :

• Engineering, Technical, or Scientific discipline with years of related experience in Medical Device industry
• Prepare and approve Production Parts Approval Product (PPAP) documents- Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA), Process Failure Mode Effect Analysis (PFMEA) and verify supplier standards.
• Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.
• Qualifies suppliers according to company standards and administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Performs CTQ remediation, gap assessment, Supplier Quality strategy, Supplier Agreements, Supplier scorecard rating and Supplier Assessments.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Support, review and approval of Validation (IQ/OQ/PQ), MSA and Control Plan from suppliers related to product introduction or transfers.
• Coordinates (CAPA) Corrective and Preventive Action life cycle, Risk Mgmt. & Analysis, Supplier Controls, Process Validation, Product Acceptance Sampling, Approved Supplier List, Design of Experiments (DOE), Gage Repeatability & Reproducibility (GR&R) and Geometric Dimensioning and Tolerancing (GD&T).
• Leverage GMP (Good Manufacturing Practices). Navigates the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.

Job Type: Full-time

Pay: $50.00 - $55.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Work Location: In person

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