Location CountryAustraliaVacancy NameQuality Assurance ManagerVacancy NoVN411Employment TypeFull-TimeDurationDivisionQualitySummary of RoleEnsuring the quality, legal and regulatory compliance of SDI products throughout their lifecycle, from design and development to manufacturing to distribution.Overseeing the implementation and maintenance of a robust quality system (QMS) in accordance with current standards, best practices, legal and regulatory requirements such as ISO 13485, MDSAP, EU MDR, QMSR (US), ARGMD (AU), ANVISA MD Regulations (Brazil), KGMP & MDM&QC standards (South Korea), NMPA's Decree 739 Regulation on Supervision and Management of Medical Devices (China), SOR/98-282 (Health Canada), PMD Act (Japan) etc.Accomplishing quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.Contributing to the development and implementation of Quality systems, policies and 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 ResponsibilitesLeads, coordinates, and plans the work within the QA teamCoaches and leads QA Team to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working accurate up-to-date documentation related to SDI's QMS, including procedures, records, and reports.Provides Quality Assurance input throughout the product development process to ensure quality is built into the design.Implements risk management systems and processes to identify and mitigate potential risks and product quality and safety.Implements and conducts internal audit programs to identify areas for improvement.Prepares for inspections/audits by with R&D, Engineering, Manufacturing and Marketing to ensure that quality is integrated into all aspect of the product lifecycle.Oversees and ensures the following QA activities are up to date, maintained, analysed, trended and reported into Management regularly:o Customer complaints handling and reportingo NCRo CAPAo Trainingo Change controlo Internal auditso Supplier & Subcontractor auditso External (3rd party) auditso Subsidiary auditso QMS Documentationo Post Market Surveillance (PMS)Assists validation activities across various departments such as Production, R&D and EngineeringWorks with Procurement with supplier qualification and evaluationContributes to Quality strategies for Continuous Improvement across the businessCollaborates with the Quality Control Manager to train and motivate employees to ensure quality standards are metAchieves quality assurance operational objectives by contributing to information analysisStays current on applicable laws and regulations to ensure complianceActs as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities of this PRRC include:o Reviews and approves the conformity assessment of the device's technical documentation before market release.o Ensuring that the device being released from routine manufacturing have been manufactured in accordance with SDI's QMS procedures and QC release criteria are traceable to the device Conducts periodic sampling of batch release PRRC shall suffer no disadvantage within the business in relation to the proper fulfilment of their duties.Supports Top Management in the promotion of SDI Quality policy and objectives.Oversees and ensures the following QA activities are up to date, maintained, analysed, trended and reported into Management regularly:o Customer complaints handling and reportingo NCRo CAPAo Trainingo Change controlo Internal auditso Supplier & Subcontractor auditso External (3rd party) auditso Subsidiary auditso QMS Documentationo Post Market Surveillance (PMS)Assists validation activities across various departments such as Production, R&D and EngineeringWorks with Procurement with supplier qualification and evaluationContributes to Quality strategies for Continuous Improvement across the businessCollaborates with the Quality Control Manager to train and motivate employees to ensure quality standards are metAchieves quality assurance operational objectives by contributing to information analysisStays current on applicable laws and regulations to ensure complianceActs as internal (outside the EU) Person of Responsibility for Regulatory Requirements (PRRC). Key responsibilities of this PRRC include:o Reviews and approves the conformity assessment of the device's technical documentation before market release.o Ensuring that the device being released from routine manufacturing have been manufactured in accordance with SDI's QMS procedures and QC release criteria are traceable to the device Conducts periodic sampling of batch release PRRC shall suffer no disadvantage within the business in relation to the proper fulfilment of their duties.Supports Top Management in the promotion of SDI Quality policy and objectives.Drives a thorough understanding of current Quality policies and objectives throughout the CompanyKey Relationships (Internal & External)All key SDI personnelExternal suppliers, contractors and consultantsRegulatory auditors such as TGA, DQS, CSA, Inmetro, UL etcJob EnvironmentPosition is located at Bayswater Head OfficeWorking hours: 10-day fortnightLocal, interstate and international travel as required.Education LevelBachelor's DegreeEssential ExperienceAware of SDI's current Quality policy and objectivesStrong working knowledge of ISO13485, MDSAP, EU MDR, 21 CRF, SOR/98-282, Regulation (EC) No 1223/2009, FDA MoCRA, IEC 60601-1 etc.Strong understanding of MDR post-market surveillance requirements (Article 83 to 86) and any additional non-EU country specific requirementsExperience with audit processesKnowledge of quality management systems.Experience in enforcing Quality requirements within the business.Experience in motivating, training and monitoring staff performance.Knowledge and skillsAware of SDI's current Quality policy and objectivesPersonal QualitiesClearly understands the role of Quality in supporting customer service.Sense of urgency and commitment for achieving agreed and challenging targets.Identify and implement innovative ideas.Identify and address short and long solutions to production problems.Understands the Quality and Safety requirements in the production environment.Classification LevelNon-AwardCurrencyAUDSalary Minimum$100,000.00Salary Maximum$140,000.00Salary PeriodPer AnnumBenefits
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