Qualtiy Assurance Engineer
HyperLight · Cambridge, MA · 3 days ago
On-siteEngineering$65k–$145k/yrFull-time
About the role
The Quality Engineer will ensure that all materials, in-process work, and finished products consistently meet defined quality standards. They will perform IQC and OQC inspections, document control, change control evaluation, and internal auditing.
Responsibilities
- Inspection
- Receive and sample-inspect incoming materials, components, and sub-assemblies against defined specifications (IQC)
- Operate measurement equipment including calipers, microscopes, and fiber-alignment tools at the inspection workstation
- Perform final acceptance inspection on finished products prior to shipment (OQC)
- Document Control
- Verify test reports, certificates of conformance, and labeling completeness
- Raise non-conformance reports (NCRs) and coordinate quarantine or return-to-vendor (RTV) actions
- Log inspection data and maintain lot-traceability records
- Document Control
- Document SOPs, work instructions, inspection criteria, and engineering drawings
- Ensure obsolete documents are withdrawn from production and correctly archived
- Carefully manage document review cycles and remind document owners
- Review new or revised SOPs, test procedures, and inspection plans for technical accuracy and compliance
- Provide QE sign-off within the document approval workflow (ECO / DCO routing)
- Auditing
- Write audit reports documenting findings, observations, and opportunities for improvement (OFIs)
- Track corrective action closure from prior audit findings
- Conduct or support supplier quality audits and assess vendor quality systems
- Serve as host and liaison during customer or third-party certification audits
- Change Control
- Evaluate engineering change requests (ECRs/ECOs) for quality impact on product, process, and documentation
- Facilitate FMEA updates and risk assessments triggered by engineering changes
- Determine re-validation or re-qualification requirements resulting from changes
- Coverage of document updates, training, and material disposition in support of approved changes
- Monitor change implementation on the production floor and verify effectiveness prior to closure
- General Support Activities
- Support and maintain the company Quality Management System (QMS) in accordance with ISO standards
- Drive corrective and preventive action (CAPA) processes including root cause analysis, corrective actions, and effectiveness verification
- Collaborate with cross-functional teams including design, product/test engineering, reliability, and operations to resolve quality issues
- Support/Work with external semiconductor manufacturing partners including wafer foundries and OSAT assembly/test suppliers to ensure product quality and process control
- Support supplier quality management activities including supplier qualification, supplier corrective actions, and supplier performance monitoring
- Support failure analysis investigations including coordination with internal teams and external manufacturing partners
- Participate in New Product Introduction (NPI) activities including PLC process, quality planning, risk assessments, and manufacturing readiness
- Develop and maintain quality procedures, work instructions, and documentation as required by the QMS
- Promote continuous improvement initiatives across engineering, manufacturing partners, and supply chain
- Bachelor's degree in Engineering, Manufacturing, Materials Science, or a related technical discipline
- 2+ years of experience in a Quality Engineering or Quality Assurance role, preferably in a photonics, fabless semiconductor or electronics environment
- Hands-on experience conducting IQC and OQC inspections in a cleanroom or ESD-controlled environment
- Familiarity with optical or photonic device inspection is a plus
- Working knowledge of ISO 9001 quality management system requirements
- Experience supporting or participating in internal, supplier, or third-party certification audits
- Familiarity with document control principles and change control processes (ECO / ECR / DCO workflows)
- Exposure to FMEA, risk assessment methodologies, and corrective action processes
- Proficiency with measurement and inspection equipment (calipers, microscopes, fiber-alignment tools, or equivalent precision instruments)
- Experience working within a SharePoint DMS, ERP, or PLM system for document and change management
- Strong attention to detail with a methodical approach to inspection and documentation
- Ability to manage multiple concurrent responsibilities spanning hands-on floor work and administrative tasks
- Effective communicator across cross-functional teams including engineering, operations, and regulatory
- Self-directed and organized, with the ability to manage time-sensitive document approval queues
- Comfortable working in a mixed environment including production floor, cleanroom, and office settings
- Experience with ISO 27001
- Familiarity with lot traceability, certificate of conformance (CoC) review, and OQC release processes
- Prior involvement in supplier qualification or vendor audit programs
- Experience working with semiconductor wafer fabrication, assembly, and test processes
- Experience managing quality interactions with semiconductor foundries and OSAT partners
- Experience with quality tools such as FMEA/8D/SPC/Control Plan/Six Sigma
- Proficiency in English, with Mandarin advantage for frequent global communication
- Competitive market-based compensation (Salary range $65,000 - $145,000)
- Comprehensive health coverage, including medical, vision, and dental plans for individuals and families
- 401(k) retirement plans with employee matching
- Paid Parental Leave
- Life and disability insurance
- Commuter benefits and subsidies
- Professional growth and mentorship opportunities