Senior Product Quality Assurance Engineer

Job Summary

GlobalProduct Quality supports and collaborates with the Engineering group and Cross Functional teams to enable a diverse range of product releases in an efficient and compliant way.

The role isfocused onenabling new strategies, platform products, Incubation and Growth areas,from Concept to commercial launch,monitoringand sustaining phases for Digital Software Products. This includes understanding emerging technologies in Digital Health, artificial intelligence, machine learning etc. In addition, the Lead Engineer will provideexpertisetodriveimprovements indesign control processes, systems and toolsandenableproduct releasesfor ResMed’s Digital products. This role is not a Software QA testing role, it is a Design Quality Engineer role

Let’s talk about Responsibilities

DefineGlobalProduct QualityStrategiesand provide/ influencestrategic directionforNew Product Development projectsin new or complex areasas a Product Quality Subject Matter Expert for compliance with FDA QSR, MDSAP, IEC 62304, ISO 114971, ISO 13485, MDR/MDD and other applicable global regulatory requirements and standards.

Applybalanceofrisk, regulatory intent and business needs to come to efficient and effective solutions for improvementsin design controls.Define these strategies by close collaboration with stakeholders, considering benefit-risk, consistency across projects and starting with a “yes” mindset.

Develop project QA plan to enable new product implementation or changes to the released product in an efficient way that satisfies ResMed’s Quality System, regulatory requirements,riskand project timing. Review and provide guidance to PD teams for Product Development deliverables to ensure they are completed accurately and efficiently.

Partnerwithother quality team memberstoensure smoothtransition ofprojectsto ongoingCross-functional teammanagement.Provideexpertiseto and support other Global Product Qualityteam membersasrequired.

Actively engage,collaborateand build relationshipswith stakeholdersand leaders, including Engineering, QA,RAand other cross functional partnerstounderstand business/department needs, risks and concerns.Build this consideration intostrategy planning and proposalsto close gaps in an efficient, technical, and compliant manner.

Key subject matter expert for quality department in design controls and best practice, actively keep up to date with latestquality standards, requirements and best practices while applying them to ResMed processes; provide thought leadership inquality aspects to rest of team / business. Maintain strong knowledge in these areas for software in bothmedical and adjacent industries.

Become familiar with the applicable technology tofacilitateparticipation in technical discussions and risk-based decision making.

Identifyareas and opportunities to improveQMSprocesses

Keep the managementup to dateon the Digital Health developments,relevant standards,requirementsand best practiceswhile applying them to ResMed processes,andprovide training, guidance,interpretationand mentorshipas neededto variousEngineering, stakeholder, QARA team members.Assistin capability development and upskilling ofProduct QualityEngineers.

Participate and lead supportofinternal and external audits within the relevant areas.Participate in investigations and ensure CAPA findings, risks,recommendationsand outcomes areappropriateand are clearly documented and communicated.

Act as Quality Subject matter expert to lead critical projects in areas of Software product development,design controls, verification & validation, risk management, qualifications, and human factors forSaMD,AI/ML models, Platform, IoT projects etc.

Provide consultation to end users and process owners with regards to quality data collection,analysisandcreation of validation reports, develop recommendations based on data analysis.

Let’s talk about Qualifications and Experience

Required:

• Degree in Engineering, Computer Science,Biomedical,Science or other tertiary qualificationsdeemedappropriate forthis position.Significant experiencein relevant roles,e.g.5-8+ years of experience in design quality.Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO Qualitystandards/regulations,includingISO13485, ISO14971 and IEC62304 for software development.Experience withSaMD(Software as A Medical Device).Supports processes such as CAPAs, and developing QualitymetricsDemonstrated ability toaccomplishgoals and embrace change while workingwithProductDevelopmentstakeholdersisrequired:Strong knowledgeofcurrentgood designpractices for software, applicable design control elements that can be applied for software in medical and non-medical projects.Real-world experienceinleadingcritical projects in areas of Software product development, design controls, verification & validation, risk management, change controlforSaMDor SystemprojectsExperience coordinatingissue resolution using a risk-based approach.Strong analytical and problem-solving skills, with a focus on continuous improvement.Excellent written,verbal communicationand collaborationskills with a strong ability to negotiate and influencePreferredExperience with Class I and Class II medical devices,EU MDR,MDDS (Medical Device Database Systems), CDS (Clinical Decision Support) devices.Project managementexperience/qualificationRecent strong experience working on System/ Platform and Software medical projects preferred.Experience handling medical and non-medical projects.Risk Management experience (Hazard analysis, FMEA, Safety risk assessments)Third partyAudit experience(MDSAP, ISO recertification, FDA QSR auditsetc)Experience implementing new standards/ regulations/ best practicesin QMS/ Software developmentand training cross-functional team members.Basic understanding of Statisticaldataanalysis fortesting.Applied experience with quality and statistical analysis tools (SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis).Quality Certification preferred (e.g.,ASQCQE,CSQE,Six Sigma etc.)Familiarity with EU GDPR, AI laws, otherUSand International AI regulations/ standards/guidanceswould also be considered an asset.At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  A reasonable estimate of the current base range for this position is:$117,000 - $220,000 USD.

Degree in Engineering, Computer Science,Biomedical,Science or other tertiary qualificationsdeemedappropriate forthis position.

Significant experiencein relevant roles,e.g.5-8+ years of experience in design quality.

Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO Qualitystandards/regulations,includingISO13485, ISO14971 and IEC62304 for software development.

Experience withSaMD(Software as A Medical Device).

Supports processes such as CAPAs, and developing Qualitymetrics

Demonstrated ability toaccomplishgoals and embrace change while workingwithProductDevelopmentstakeholdersisrequired:

Strong knowledgeofcurrentgood designpractices for software, applicable design control elements that can be applied for software in medical and non-medical projects.

Real-world experienceinleadingcritical projects in areas of Software product development, design controls, verification & validation, risk management, change controlforSaMDor Systemprojects

Experience coordinatingissue resolution using a risk-based approach.

Strong analytical and problem-solving skills, with a focus on continuous improvement.

Excellent written,verbal communicationand collaborationskills with a strong ability to negotiate and influence

Experience with Class I and Class II medical devices,EU MDR,MDDS (Medical Device Database Systems), CDS (Clinical Decision Support) devices.

Project managementexperience/qualification

Recent strong experience working on System/ Platform and Software medical projects preferred.

Experience handling medical and non-medical projects.

Risk Management experience (Hazard analysis, FMEA, Safety risk assessments)

Third partyAudit experience(MDSAP, ISO recertification, FDA QSR auditsetc)

Experience implementing new standards/ regulations/ best practicesin QMS/ Software developmentand training cross-functional team members.

Basic understanding of Statisticaldataanalysis fortesting.

Applied experience with quality and statistical analysis tools (SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis).

Quality Certification preferred (e.g.,ASQCQE,CSQE,Six Sigma etc.)

Familiarity with EU GDPR, AI laws, otherUSand International AI regulations/ standards/guidanceswould also be considered an asset.

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.  A reasonable estimate of the current base range for this position is: .

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!