Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is protected or helping find cures for cancer.
DESCRIPTION: We are seeking an Engineer III - Quality Systems & Documentation to lead quality documentation standardization, supplier quality governance, and Bill of Quality (BOQ) readiness across the global Contract Manufacturing network.This role will partner with Quality, Manufacturing Engineering, Regulatory, Procurement, Operations, and external manufacturing partners to establish consistent quality documentation frameworks, improve audit readiness, support technology transfers, and strengthen supplier quality performance through disciplined documentation and governance.Key ResponsibilitiesDevelop and deploy quality documentation frameworks, templates, standards, and governance routines across Contract Manufacturing partnersSupport Bill of Quality (BOQ) framework development including quality requirements, inspection controls, validation evidence, risk controls, and supplier documentation expectationsDefine and maintain supplier quality documentation requirements for technology transfers, product changes, new supplier onboarding,



and ongoing production supportPartner with Quality and Operations teams to ensure documentation aligns with applicable quality management systems, regulatory expectations, and internal standardsSupport audit readiness by ensuring controlled documents, evidence packages, change records, and supplier quality files are accurate, complete, and retrievableReview and improve supplier quality documentation including control plans, inspection plans, validation records, nonconformance data, CAPA evidence, and risk documentationSupport quality risk assessments, process FMEAs, control strategy development, and issue resolution related to external manufacturing operationsLead continuous improvement initiatives to reduce documentation defects, improve right-first-time quality, and strengthen supplier governanceContribute to technology transfer readiness reviews by evaluating quality documentation completeness, inspection readiness, and process control maturityMaintain quality best-practice libraries, quality playbooks, lessons learned, and reusable templates for global deploymentPartner with digital and documentation teams to improve quality record structure, searchability, version control, and lifecycle governanceMinimum QualificationsBachelor's degree with 8+ years of experience or Master's degree with 6+ years of experience in Quality Engineering, Manufacturing Engineering, Life Sciences,



Industrial Engineering, or a related technical disciplineExperience in quality systems, supplier quality, manufacturing quality, documentation control, or regulated manufacturing operationsPreferred QualificationsExperience supporting Contract Manufacturers, OEMs, supplier quality management, or external manufacturing operationsKnowledge of ISO *****, FDA Quality System Regulation, ISO ****, GMP, risk management, CAPA, audit readiness, and change control processesExperience developing quality documentation standards, quality plans, inspection requirements, and supplier quality recordsWorking knowledge of process validation, verification, FMEA, control plans, nonconformance management, and corrective action systemsExperience supporting regulated industries such as Medical Device, Life Sciences, Diagnostics, Pharma, Analytical Instruments, or AerospaceFamiliarity with PLM, ERP, eQMS, document management systems, SharePoint, or quality records platformsStrong ability to interpret quality requirements and convert them into practical documentation and governance processesStrong analytical, communication, and stakeholder management skills in a global matrix environmentCertification such as ASQ CQE, CQA, Six Sigma Green Belt, or Lead Auditor preferredKey CompetenciesQuality systems thinking with strong compliance disciplineSupplier quality governance and documentation excellenceRisk-based decision-making and structured problem solvingAudit readiness and attention to detailCross-functional collaboration and influenceContinuous improvement orientationStrong ownership of quality outcomes and customer impact
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📌 Engineer Iii - Quality Systems & Documentation (New South Wales)
🏢 SwiftCruit
📍 New South Wales