Location CountryAustraliaVacancy NameMechanical Engineer - Validation & Continuous ImprovementVacancy NoVN405Employment TypeFull-TimeDurationDivisionEngineeringSummary of RoleThe Mechanical Engineer – Validation & Continuous Improvement is responsible for:Supporting equipment validation, quality assurance, and continuous improvement initiatives across our manufacturing towards SDI Strategic Priorities.Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and ResponsibilitesDevelops, executes and documents validation protocols (IQ, OQ and IOQs) for manufacturing equipment in line with TGA, ISO 13485 and FDA requirementsPrepares machine work instructions.Updates CMMS with all assets details and PMsAssists in project planning, scheduling and tracking of engineering deliverablesCollaborates with cross-functional teams including Quality, R&D, Manufacturing and Regulatory AffairsIdentifies opportunities for process improvement and support lean / Six Sigma initiativesConducts root cause analysis (RCA) and implements corrective and preventive actions (CAPAs)Supports design review, risk management and change control activitiesUpdates the details and PMs for all assets that got RIQ generated in MEXMaintains proper storage of all documents in SDI shared foldersUpdates the validation master planGenerates work instruction for all assets that got RIQsKey Relationships (Internal & External)Engineering TeamProduction TeamProjects TeamQuality TeamR&D TeamOperations TeamJob EnvironmentThe position is located at Bayswater Head Office and eventually at MontroseWorking hours: Full Time 38 Hours per weekLocal travel as required.Education LevelBachelor's DegreeEssential ExperienceBachelor's degree in mechanical engineering or a related discipline0–3 years of experience in a manufacturing, medical devices or engineering environmentKnowledge and skillsAware of SDI's current Quality policy and objectivesExcellent written and verbal communication skillsMust have strong written and verbal communication skillsFamiliarity with equipment qualification under a regulated environment (ISO13485) is desirable.Familiarity with FMEA, risk management or design controls is desirable.Strong analytical and problem-solving skills with high attention to detailProficient in CAD software (SolidWorks, AutoCAD or equivalent)Personal QualitiesSolid experience working as part of a customer focused organization with strong emphasis on both internal and external customer service.Influencing and strong communication skills.High level precision and organised workflow.Solid understanding of HACCP, GMP and OHS requirements.Flexible, open to change and possess the ability to work well under pressure.An ability for creative thinking, tenacity, and dedication to deliver validation work on time.Collaborative and inclusive team cultureClassification LevelSpecialCurrencyAUDSalary Minimum$85,000.00Salary Maximum$105,000.00Salary PeriodPer AnnumBenefitsSuperannuationCar parkComprehensive onboarding and ongoing professional development
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