Quality Engineer Supplier & Product Assurance
Listed on 2026-02-03
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Quality Assurance - QA/QC
Quality Engineering, Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector -
Engineering
Quality Engineering, QA Specialist / Manager
Overview
Summary The Quality Engineer – Supplier & Product Assurance provides enterprise-level oversight of supplier and product quality across diverse product lines, manufacturing models, and supplier environments. This role ensures that all materials and products conform to established Quality Control Conformance Requirements (QCCs), relevant standards, and regulatory obligations. The position is responsible for supplier qualification, first article inspections, incoming inspection processes, and product release, while working cross-functionally with Supply Chain, Engineering, Operations, Compliance, and Safety teams.
The ideal candidate will demonstrate strong analytical skills, thorough knowledge of ISO 9001-based systems, experience in supplier audits, and the ability to lead corrective and preventive action (CAPA) initiatives. This individual must be adaptable, highly collaborative, and capable of driving structured problem-solving and continuous improvement. Travel up to 25% is expected.
Key Responsibilities- Supplier Evaluation, Qualification & Approval
- Conduct supplier approval and qualification activities, including review of documentation, supplier segmentation, and risk-based assessments.
- Determine qualification depth, surveillance level, and audit strategy based on supplier risk, capability, and compliance.
- Provide justification for qualification, periodic surveillance, and for-cause audits.
- Supplier Development
- Communicate and reinforce Osmose quality expectations and Quality Assurance requirements with existing and new suppliers.
- For suppliers requiring corrective action, partner with Supply Chain to define, execute, and track Quality Corrective Action Plans that reduce defects, improve compliance, and ensure sustained performance.
- First Article Inspections (FAI)
- Lead First Article Inspection processes for new or revised products.
- Collaborate with suppliers to optimize quality, productivity, and cost efficiency through improved manufacturing processes.
- Quality Assurance & Compliance
- Develop and implement quality assurance plans for contract manufacturers and key suppliers.
- Ensure compliance with QCCs, including batch record evaluation, process controls, critical quality characteristics, and deviation management.
- Monitoring, Reporting & Quality Systems Effectiveness
- Analyze internal and external quality data, field feedback, and manufacturing trends to evaluate systemic risk and quality system effectiveness.
- Track supplier performance metrics, defect trends, test results, and quality notifications.
- Prepare reports on supplier quality issues, product concerns, and continuous improvement opportunities.
- Incoming Inspection & Product Release
- Own and administer the incoming inspection program for purchased materials and products.
- Develop and maintain sampling plans, inspection criteria, and product acceptance standards.
- Ensure all incoming materials are evaluated against specifications and dispositioned per established processes.
- Product Manufacturing & Distribution Oversight
- Verify supplier and contract manufacturer adherence to QCCs throughout production and distribution processes.
- Partner with Supply Chain and Operations to resolve manufacturing or distribution-related quality concerns.
- Conduct statistical analysis of process data to identify variation, risk, and improvement opportunities.
- Root Cause Analysis & CAPA Leadership
- Lead structured investigations into quality issues using tools such as 5 Whys, Fishbone, FMEA, and other root-cause methodologies.
- Facilitate corrective and preventive actions with suppliers and internal stakeholders.
- Cross-Functional Collaboration & Lifecycle Support
- Support Engineering, R&D, Operations, Compliance, and Safety teams in supplier performance reviews, product testing, and design-for-quality efforts.
- Provide QA input throughout product development and lifecycle processes.
- Bachelor’s degree in Engineering, Science, or a related technical field.
- 3+ years in Supplier Quality, Product Quality, or Manufacturing Quality roles.
- Strong knowledge of ISO 9001-based quality systems and quality tools (FMEA, control plans, etc.).
- Experience conducting supplier…
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