Peng-Jen C. Email & Phone Number

Austin, Texas, United States

• Deviation (Interim Control) Management• Oversee the deviation process and coach owners to define deviation scope, actions, and duration, and closely collaborate withstakeholders to secure timely progress, resolution of roadblocks and compliance• Reduce the use of deviation by over 75% and keep the deviation duration within 90 days to ensure appropriate use of interim control• Revitalize SOP and work form with guidance and clarification to facilitate compliance and improve documentation accuracy• Standard and Regulatory Requirement Maintenance• Monitor standard and regulation updates and work with SMEs to ensure thorough and accurate gap assessments and timelycompletion of identified actions, maintaining continuous compliance with evolving standards• Restructure the procedure and the work form to provide clear guidance on the assessment process, ensuring a streamlined workflow• Quality Metrics• Extract data and generate weekly graphs and charts to provide customer with insight and visibility to trends and performance,maintaining transparency and addressing any concerns promptly• Improve efficiency and minimize human errors by developing an Excel-based solution to streamline graph/chart generation• NCMR Coordination• Lead daily NCMR status meeting to secure timely resolution and facilitate on-time shipment• Act as the liaison between multiple departments to direct support and resources to the correct stakeholders

Austin, Texas, United States

• Supplier Quality Management• Coached suppliers on Juul Labs standards and streamlined the implementation verification process for Juul Labs' changes andsupplier change requests by establishing standardized requirements for evidence, enhancing efficiency and clarity• Created inspection instructions (AQL sampling) and specifications for new packaging components• Communicated with suppliers on a weekly basis to track sustaining projects, nonconformance, SCARs, and other initiatives• Identified, assessed, and resolved quality incidents on the production line and escalated to SCARs when necessary to ensure suppliersclosed the gaps in their process• Conducted supplier audits to confirm compliance with ISO and Juul Labs standards• Quality Management System• Investigated and resolved nonconformance within Juul Labs' ISO 13485:2016 quality management system• Led CAPA through initiation, investigation, implementation and verification phases to solve deficiencies in existing processes• Reviewed and updated quality documents with compliance assessment and documented changes following GDP guidelines• Packaging and Labeling Quality• Reviewed and approved artwork for product packaging by verifying compliance to specifications and respective regulatoryrequirements, and implementation of planned changes• Established color standard for packaging materials and procedures and instructions of color determination and inspections throughcross-functional collaboration

Lolita, Texas, United States

ISO 9001:2015 Quality ManagementMaintained ISO 9001:2015 compliance by monitoring daily documentation and traceability review, and ensuring quality procedures were followedParticipated in ISO 9001:2015 surveillance and certification audits and internal audits, contributing to the continuous improvement of quality managementMonitored and investigated customer complaints and nonconformances to identify areas for improvement and enhance customer satisfactionQuality Control Lab SupervisorSupervised and managed a team of 5 technicians in the QC lab, ensuring compliance with ISO 9001:2015 standardsCollaborated with production and shipping teams to maintain quality standards and ensure on-time shipmentReviewed and improved testing requirements and procedures to enhance testing efficiency and accuracyEnsured compliance with quality procedures and verified lab operations were in accordance with established standardsSupplier and Intracompany CollaborationCollaborated with suppliers to develop improved product recipes for enhanced product performance and cost savingsEstablished supplier relationships to secure a reliable supply of raw materials at a lower costWorked with other business units and customers to develop new products in the pavement and tag and label markets, resulting in new revenue streamsEffectively communicated with suppliers for immediate actions on defective materials to reduce impacts on production

Dayton, Ohio, United States

Taichung City, Taiwan

Taipei City, Taiwan

Master Of Science - Ms, Materials Science And Engineering

Bachelor Of Science - Bs, Materials Science And Engineering