Quality Assurance Engineer

Our growing team is looking for a Quality Engineer to join our team in Cambridge, MA. In this role, you will ensure that incoming materials, in-process work, and finished products consistently meet defined quality standards. Your responsibilities will span IQC and OQC inspections, document control, change control evaluation, and internal auditing - all in support of a quality management system registered to ISO 9001, enabling the organization to deliver reliable, specification-conformant products while maintaining continuous improvement and regulatory readiness.

- 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)

- Verify test reports, certificates of conformance, and labeling completeness

- Raise non-conformance reports (NCRs) and coordinate quarantine or return-to-vendor (RTV) actions

- Maintain and version-control SOPs, work instructions, inspection criteria, and engineering drawings On SharePoint and Notion

- Ensure obsolete documents are withdrawn from production and correctly archived

- Coordinate periodic document review cycles and manage document owner reminders

- 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)

- Ensure approved documents are available at both sites prior to implementation

- Plan and execute internal process audits against ISO 9001 and applicable standards

- Write audit reports documenting findings, observations, and opportunities for improvement (OFIs)

- Conduct or support supplier quality audits and assess vendor quality systems

- Serve as host and liaison during customer or third-party certification audits

- 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

- Coordinate document updates, training, and material disposition in support of approved changes

- Monitor change implementation on the production floor and verify effectiveness prior to closure

- Support and maintain the company Quality Management System (QMS) in accordance with ISO standards

- Assist with planning and execution of supplier audits and supplier quality assessments

- 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

- Assist/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

- Support 8D/RMA and field return investigations to identify root causes and implement corrective actions

- 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)

- Ability to read and interpret engineering drawings, specifications, and test procedures

- Experience working within a SharePoint DMS, ERP, or PLM system for document and change management

- Competence in writing clear, accurate technical documents including NCRs, audit reports, and inspection records

- 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

- 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

- Proficient in English and advantage to have Mandarin, as required for working with our global team frequently

- 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