Supplier Quality Engineer

Supplier Quality Engineer

  Not Disclosed

  Palo Alto, CA

  5.0 Months

  Not Disclosed

  Not Disclosed

  Healthcare

  $68/hour - $73/hour

Job Description

On-site: 4 days/week minimum. 1 day/week flexible (remote).

Description:


Primarily responsible:
1. Site-Focused Tactical Supplier Responsibility
Manage tactical supplier responsibilities at the site level, ensuring supplier performance aligns with immediate operational and quality requirements in QII, Manufacturing, and Field Service.

2. Immediate Quality Assurance and Operational Support
Ensure immediate quality requirements are met by identifying and mitigating supply quality risks, addressing Qnotes, and focusing on MRB processes to reduce scrap and minimize operational disruptions.

3. Key Activities in Supplier Management
Lead small-scale improvement projects with suppliers.
Manage day-to-day supplier communication and relationships.
Support supplier evaluations and drive compliance to quality standards.

4. Cross-Functional Collaboration
Foster collaboration with Production, Manufacturing Engineering, Operational Procurement, installation and service, SQMs, and other Subject Matter Experts to ensure operational efficiency and problem resolution.

5. Supplier Performance Monitoring and Improvement
Use tools like the PQ/SQ Dashboard to track supplier performance metrics, such as Qnotes turnaround, and implement targeted actions to achieve measurable improvements in supplier quality.

Core Competencies
1. Enhance Cross-Functional Collaboration

Build strong partnerships with Production, Manufacturing Engineering, Service, and Procurement teams (Strategic AND Operational).
For assigned parts and suppliers, engage in New Product Introduction (NPI) processes with PLM and SCM to ensure client requirements are (using QATS tools) manufacturable, and the supplier’s feedback on the client specification is reviewed and dispositioned in the NPI phase (or earlier)
Maintain onsite presence to strengthen relationships with cross-functional team members.
Partner with internal customers to address supplier quality issues promptly. As appropriate participate in daily AVM meetings, and ensure timely resolution of non-conformities, MRB support, Qnotes dispositions, and NPI deliverables.
Collaborate with suppliers to ensure adherence to material specifications and quality requirements.
Support QII with First Article Inspections and development of Inspection Plans.
Work with Engineering and Suppliers to define clear specifications, CTX attributes, and material acceptance criteria using proactive quality planning, emphasizing manufacturability and reliability.
Partner with R&D, Design Engineering and Manufacturing Engineering to engage suppliers early in the NPI process and provide DFM feedback to improve designs.

2. Communication of Escalated or Emerging Issues

Keep Management and Operational Teams informed of any escalated or emerging supply chain and operational risks.
Work with the service team to review field data, and ensure parts are returned and analyzed by the supplier (where appropriate) to define clear root cause and corrective action to improve both factory AND field performance.
Provide regular, clear, and evidence-based updates, including key findings, root causes, actions taken, mitigations, and recommendations, using approved templates where applicable.
Ensure consistent communication to convey status updates and highlight any needs for support or additional resources.

3. Reduce Supplier Quality Issues Impacting Manufacturing, Installation and Service

Be the client Subject Matter Expert on assigned suppliers processes to ensure a full understanding of the potential risks and rapid resolution of part non-conformances at the supplier.
Minimize supplier quality problems affecting manufacturing operations, installation and service operations and customers, and other parts of the client business.
Perform root cause analysis and implement corrective actions for immediate quality concerns.
Ensure timely execution and closure of the SCAR process while driving continuous improvement initiatives and supporting SQM with Supplier Development Plans.
Follow up on open supplier issues to ensure effective resolution with all stakeholders.
Actively manage and coordinate SCN with relevant departments to maintain quality and compliance.

4. Lead QATS Implementation with Targeted Suppliers

Drive increased part acceptance through QATS criteria and data review, ensuring supplier parts fully meet client requirements. This will require the SQE to engage with suppliers on the client QATS tools and KPI’s to ensure proactive supplier engagement on compliance to client specifications and requirements. Tools include PFMEA, SPC, MSA, Cpk analysis, Control Plans. More may be added as the QATS program is maturing.
Improve QII efficiency by reducing the need for client inspections and shifting supplier incoming materials from inspection to data review.
Identify targeted suppliers with high-risk or failing parts, or low-risk parts suitable for data review, and conduct necessary reviews, alignments, risk managements, MSA studies, and validations to implement quality at the source.
Collaborate closely with suppliers to ensure their processes meet design specifications and quality standards through effective internal process controls.

5. Reduce Warranty and Non-Conformance Costs

Drive initiatives to lower overall quality costs.
Analyze warranty and non-conformance expenses, identify root causes, and implement targeted action plans to address and resolve issues.

6. Supplier Audits

Conduct For Cause audits to address specific risks or recurring quality issues.
Identify root causes, document findings, and drive timely corrective actions with suppliers.
Ensure alignment with quality and compliance requirements through follow-up and resolution

Top Must-Have Skills
Technical Problem Solving
Root cause analysis (e.g., fishbone, 5 Whys).
DOE (Design of Experiments).
Driving supplier corrective actions (prevention & detection controls).

Six Sigma / Statistical Analysis
Familiarity with CP/CPK, SPC, control charts, run charts.
Experience with Minitab or JMP software.
Certification (e.g., Six Sigma, CQE) is a plus, not required.

Critical Thinking
Ability to ask probing questions to suppliers.
Drive actions and assess risks effectively.

Nice-to-Have Skills
CQE certification (Certified Quality Engineer).
Kaizen / Continuous Improvement experience.
Engineering capabilities:
CAD knowledge.
Understanding of schematics.
Experience with cable parts used in oncology systems (radiation therapy equipment).

Knockout Criteria
Must be able to explain validation clearly.
If a candidate cannot explain validation, they are not a fit.

Notes:
8am to 5pm
On-site: 4 days/week minimum.
1 day/week flexible (remote).