What are the responsibilities and job description for the Supplier Quality Engineer position at Stark Pharma Solutions Inc?
Job Title: Supplier Quality Engineer
Location: Bothell, WA
Duration: 06-12 Months
Role Summary
The Supplier Quality Engineer (SQE) is responsible for managing supplier quality performance by investigating supplier-related defects, driving corrective actions, and collaborating with cross-functional teams to resolve quality issues. The role includes reviewing material rejections, participating in MRB activities, managing quality notifications and supplier corrective actions, supporting supplier and design change qualifications, and ensuring continuity of supply while maintaining product quality and compliance.
Key Responsibilities
Location: Bothell, WA
Duration: 06-12 Months
Role Summary
The Supplier Quality Engineer (SQE) is responsible for managing supplier quality performance by investigating supplier-related defects, driving corrective actions, and collaborating with cross-functional teams to resolve quality issues. The role includes reviewing material rejections, participating in MRB activities, managing quality notifications and supplier corrective actions, supporting supplier and design change qualifications, and ensuring continuity of supply while maintaining product quality and compliance.
Key Responsibilities
- Review and investigate supplier-caused material rejections identified during incoming inspection, warehousing, and production operations.
- Participate in daily Material Review Board (MRB) meetings to assess non-conforming materials and support disposition decisions.
- Collaborate with Manufacturing, Operations, Quality, Procurement, and Engineering teams to evaluate defects and drive containment actions.
- Perform root cause analysis for supplier-related quality issues and ensure effective implementation of corrective and preventive actions.
- Manage and maintain supplier quality notifications, non-conformance reports, and defect records within SAP or other quality management systems.
- Initiate, track, and drive closure of Supplier Quality Notifications (SQNs) and Supplier Corrective Action Requests (SCARs) within defined timelines.
- Monitor supplier performance metrics, including defect rates, rejection trends, repeat failures, and corrective action effectiveness.
- Conduct regular reviews with suppliers to communicate quality concerns, discuss performance, and drive continuous improvement initiatives.
- Analyze recurring quality issues and implement preventive measures to reduce supplier-related defects and operational disruptions.
- Support qualification and validation activities associated with supplier-initiated changes, process changes, material substitutions, and design modifications.
- Assess the impact of supplier change requests (SICRs) on product quality, manufacturing, and regulatory compliance.
- Coordinate with suppliers and internal stakeholders to ensure compliance with quality requirements, specifications, and applicable standards.
- Support risk assessments, supplier audits, and quality improvement projects aimed at enhancing supplier capability and performance.
- Maintain accurate records of supplier quality activities, corrective actions, and qualification outcomes to ensure traceability and audit readiness.
- Escalate critical supplier quality issues when necessary and facilitate cross-functional resolution to minimize business impact.
- Ensure continuity of supply by proactively identifying and mitigating supplier quality risks that could affect production schedules or customer commitments.
- Provide regular quality performance updates and reports to management, highlighting key risks, trends, and improvement opportunities.
- Part qualification (APQP)
- Bachelor s degree in mechanical engineering, Manufacturing Engineering, Industrial Engineering, Electrical/Electronic Engineering.
- Strong ability to read and interpret engineering drawings and specifications.
- Certification in quality methodologies such as ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt/Black Belt
- Background in manufacturing, supplier quality, or engineering documentation roles.
- 8-10 years of experience in Supplier Quality, Manufacturing Quality, Quality Engineering, Supplier Development, or Operations Quality.
- Experience in handling supplier quality issues, non-conformance management, and corrective action processes.
- Hands-on experience working with Manufacturing, Incoming Inspection, Warehouse, Procurement, and Supplier Management teams.
- Experience managing Supplier Corrective Action Requests (SCARs), Supplier Quality Notifications (SQNs), CAPA, and root cause investigations.
- Experience participating in or leading Material Review Board (MRB) activities.
- Experience qualifying supplier process changes, product changes, and supplier-initiated change requests.
- Experience working in regulated industries such as Medical Devices, Healthcare, Industrial Manufacturing is preferred.
- Experience interacting directly with global suppliers and driving supplier quality improvement initiatives.
- Supplier Quality Management (SQM)
- Quality Management Systems (QMS)
- Incoming Inspection Processes
- Non-Conformance Management
- Root Cause Analysis
- Corrective and Preventive Actions (CAPA)
- 8D Problem Solving
- 5 Why Analysis
- Fishbone (Ishikawa) Analysis
- PFMEA / DFMEA
- Control Plans
- Statistical Process Control (SPC)
- SAP Quality Management (SAP QM)
- Quality Notifications (QN)
- Inspection Lots
- Material Review Board (MRB) Processes