Quality Engineer

Quality Engineer

Shift: 1st shift, standard working hours from Monday-Friday Duration: 12 Months Pay range: $40.00 - $45.00 Hourly Onsite Job

Job Description:

• Partner with Manufacturing, Manufacturing Engineering, Automation, Project Management, and Supply Chain to ensure quality requirements are met throughout project execution, including build, integration, FAT, and release.
• Provide hands-on quality support on the production floor, addressing real-time quality issues related to equipment assembly, wiring, tubing, automation configuration, testing, and documentation.
• Support quality readiness for HAT/FAT and customer acceptance activities, including review of build records, test documentation, and release packages, perform and/or support IQ,OQ, PQ activities.

Quality Systems & Compliance

Develop, maintain, and approve SOPs, work instructions, templates, and quality records supporting manufacturing, integration, inspection, and release activities in compliance with cGMP, ISO 9001, and applicable ISO 13485 requirements. Ensure effective implementation and compliance to site Quality Management System (QMS) processes, including Document Control, Training, Deviations, CAPA, Change Management, and Nonconformance. Serve as the Quality representative for New Product Introduction (NPI), project customization, and Engineering Change Orders (ECOs), ensuring quality and compliance impacts are assessed and mitigated. Review and approve quality-related documentation associated with equipment builds, including inspection records, deviation reports, nonconformance records, CAPAs, and change documentation.

Investigations, Risk & Product Quality

Lead complex deviation, nonconformance, CAPA, and customer complaint investigations related to product performance, functionality, supplier issues, or documentation gaps. Apply structured Root Cause Analysis and risk management tools (e.g., RCCM, FMEA, fault tree analysis) to identify systemic issues and drive effective corrective and preventive actions. Lead MRB activities at the Santa Clara site, including disposition of nonconforming components, subassemblies, and systems, and issuance of CAPA or SCARs as appropriate. Own product ship holds for potential product escapes, including initiation, containment, cross-functional communication, risk assessment, and resolution. Support customer-facing quality actions, including field corrections, retrofit activities, and recall-related assessments, when applicable.

Supplier & Change Management

Partner with Supplier Quality, Procurement, and Engineering to address supplier quality issues impacting builds, including review and disposition of supplier nonconformances and SCARs. Review and approve ECOs, Deviations, configuration changes, and automation/software updates for quality, compliance, and customer impact prior to implementation at the site. Ensure changes affecting design, materials, assembly processes, testing, or documentation are properly assessed, implemented, and verified.

Metrics, Data & Continuous Improvement

Establish, monitor, and analyze site-level quality KPIs, including trends in deviations, CAPAs, nonconformances, supplier issues, and customer complaints. Use data and statistical analysis to identify quality risks, prioritize improvement opportunities, and drive corrective actions. Lead or actively participate in PPI, RCCM, and other continuous improvement initiatives to improve right first-time (RFT) yield, reduce rework, and enhance product quality and reliability.

Audits, Leadership & Site Ownership

Lead or support internal audits at the in alignment with Corporate, quality system requirements, applicable ISO 9001 standards and cGMP requirements. Serve as a Subject Matter Expert during customer, certification, and regulatory audits conducted at the Santa Clara site, supporting audit preparation, execution, and response. Provide day-to-day leadership, coaching, and mentorship to Quality Engineers and Quality Technicians at the site. Act as a quality escalation point for complex or high-risk issues, exercising sound, risk-based judgment and influencing cross-functional decisions. Promote and reinforce a strong culture of quality, accountability, and continuous improvement across the Santa Clara site. Perform other duties as assigned.

Education

Bachelor of Science degree in Mechanical, Process, Electrical, Automation, Biomedical Engineering, or a related technical field required; Master's degree preferred. Professional certifications such as CQE, CRE, or Six Sigma Green/Black Belt are highly desirable.

Experience

4+ years of experience in Quality Engineering or a related technical role within a regulated manufacturing environment. Demonstrated experience supporting engineered-to-order bioprocessing or capital equipment, including mechanical assembly, electrical/automation integration, and testing activities. Strong working knowledge of cGMP principles and quality standards, including ISO 9001, ISO 13485 (as applicable), ISO 14971, and ISO 17025. Hands-on experience with site Quality Management Systems, including Document Control, CAPA, Deviations, Nonconformance, Change Management, and Auditing. Experience working with ERP, PLM, MES, and electronic document control systems. Ability to interpret mechanical drawings, electrical schematics, BOMs, design control documentation, and technical specifications. Proven ability to manage multiple complex, project-driven priorities with minimal supervision.

Knowledge, Skills & Abilities

Strong verbal and written communication skills, including technical documentation and customer-facing correspondence. Excellent analytical, problem-solving, and risk-based decision-making skills. Demonstrated ability to influence cross-functional teams and site leadership without direct authority. High attention to detail, strong organizational skills, and sound professional judgment. Proficient in Microsoft Office, SharePoint, and Microsoft Teams. Ability to adapt to changing customer requirements, project schedules, and regulatory expectations in a fast-paced Santa Clara manufacturing environment.

Employee Benefits:

At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch