Quality Engineer
Swagelok Northern California
Job Description
Job Description
Description
The Quality Engineer drives continuous improvement in business performance by ensuring processes consistently deliver safe, reliable, and customer-focused outcomes. Working collaboratively with process owners, this role measures and analyzes process performance, identifies risks and opportunities for improvement, and implements sustainable corrective and preventive actions.
The Quality Engineer serves as the steward of our Quality Management System, ensuring compliance while reducing process variation, improving operational effectiveness, and enhancing customer satisfaction. The Quality Engineer leads our internal audit program to assess process effectiveness, uncover risks and opportunities for improvement, and ensures corrective actions drive measurable and sustainable improvements in business performance. Through data-driven decision making and root cause problem solving, this position helps the organization achieve its quality, delivery, and growth objectives.
Key ResponsibilitiesQuality Systems & Compliance
- Develop, execute, and continuously enhance the internal and supplier audit programs to assess process effectiveness, ensure compliance, identify risks, and drive operational improvement.
- Develop, maintain, and improve quality system documentation, process descriptions, work instructions, and manufacturing procedures to support operational excellence and standardization.
- Evaluate supplier capabilities, quality systems, and process controls to ensure conformance with organizational, customer, and regulatory requirements.
- Ensure supplier compliance with customer-specific requirements, including documentation, certifications, traceability, and quality record submissions.
- Review engineering drawings, bills of materials, routings, specifications, and related documentation to verify accuracy, completeness, and compliance with customer and company requirements.
Corrective Action & Nonconformance Management
- Own and continuously improve the Nonconforming Product (NCP) and supplier Returned Material Authorization (RMA) processes to minimize quality escapes, reduce recurrence, and protect customer satisfaction.
- Lead root cause investigations and corrective action initiatives, ensuring systemic issues are identified, addressed, and prevented from recurring through sustainable process improvements.
- Investigate, document, and resolve quality-related issues, coordinating with internal teams and external partners as needed.
- Communicate the status of quality-related issues, corrective actions, and improvement activities to Production Control, Operations, and other stakeholders.
- Attend and actively participate in Quality, Material Review Board (MRB), and other cross-functional meetings to review quality performance, resolve issues, and support continuous improvement initiatives.
Product & Process Quality Engineering
- Partner with Operations, Supply Chain, Engineering, and Quality teams to proactively prevent nonconforming products from reaching customers through effective quality planning, risk mitigation, and process controls.
- Provide quality engineering support for new and existing products through first-piece approvals, First Article Inspection Reports (FAIR), and validation of manufacturing processes.
- Participate in product and process design reviews to identify quality risks, improve manufacturability, and ensure customer requirements are adequately addressed.
- Provide technical guidance and support to Quality Technicians and inspection personnel to ensure consistent application of quality standards and inspection requirements.
Supplier Quality & Performance
- Monitor, analyze, and communicate supplier quality performance metrics, leading initiatives that improve supplier capability, reliability, and overall supply chain performance.
- Provide quality engineering support for new and existing products through first-piece approvals, First Article Inspection Reports (FAIR), and validation of manufacturing processes.
- Foster collaborative relationships across Supply Chain, Engineering, Operations, Regulatory, and Quality functions to improve process performance and achieve quality objectives.
Continuous Improvement & Data Analysis
- Analyze quality, operational, and supplier performance data to identify trends, uncover improvement opportunities, and support data-driven decision making.
- Champion continuous improvement initiatives that reduce variation, eliminate waste, mitigate risk, and improve quality, delivery, and operational effectiveness.
- Lead or contribute to strategic quality initiatives, cross-functional projects, and other assignments that support organizational objectives and continuous improvement efforts.
Skills & Competencies
- Continuous Improvement Leadership. Leads initiatives that improve quality, reduce variation, eliminate waste, and enhance operational effectiveness through the application of Lean, Six Sigma, and other continuous improvement methodologies.
- Root Cause Analysis & Corrective Action. Applies structured problem-solving methodologies, including 8D, 5 Why, Fishbone, and corrective action processes, to identify systemic issues and implement sustainable solutions.
- Quality Systems & Compliance. Demonstrates knowledge of quality management systems, auditing principles, document control practices, and regulatory or customer-specific requirements to ensure compliance and process effectiveness.
- Data Analysis & Decision Making. Utilizes statistical analysis, quality metrics, and performance data to identify trends, evaluate process capability, assess risk, and drive data-based decisions.
- Supplier Quality Management. Evaluates supplier performance, quality systems, and process controls while collaborating with suppliers to improve capability, compliance, and overall product quality.
- Technical & Engineering Interpretation. Reads, interprets, and critiques engineering drawings, specifications, bills of material, process documentation, and quality requirements to ensure product and process conformance.
- Project & Process Management. Effectively manages multiple projects, corrective actions, audits, and improvement initiatives while balancing competing priorities and meeting established timelines.
- Cross-Functional Collaboration & Influence. Builds effective working relationships across Operations, Engineering, Supply Chain, Regulatory, and Quality functions to achieve quality objectives and drive organizational improvements.
- Effective Verbal and Written Communication. Communicates technical information, quality concerns, audit findings, corrective actions, and project updates clearly and professionally to internal and external stakeholders.
- Computer & Quality Systems Proficiency. Proficient in Microsoft Office applications and quality-related systems, including ERP, document management, reporting, and statistical analysis tools.
Education & Work Experience
Required:
- Bachelor’s degree from a four-year college or university in an engineering or quality discipline
- Minimum of 5 years’ experience in a manufacturing environment (or 2 years with a Master’s Degree in related discipline)
Preferred:
- ASQ Certified Quality Engineer (CQE)
- ASQ Certified Quality Improvement Associate (CQIA)
- 100% covered employee Medical, Dental, & Vision Insurance
- Up to 80% dependent coverage for Medical, Dental, & Vision Insurance
- Life Insurance
- Health Care Flexible Spending Account
- Dependent Care Flexible Spending Account
- 401k Plan & Company Matching up to 4%
- Short-Term and Long-Term Disability
- Competitive Pay
- Generous PTO
- Paid Holidays
- Tuition Reimbursement
- Gym Membership Reimbursement up to $50/month
- Professional Coaching
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