Job Summary
Global Product 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 is focused on enabling new strategies, platform products, Incubation and Growth areas, from Concept to commercial launch, monitoring and 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 provide expertise to drive improvements in design control processes, systems and tools and enable product releases for 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
Define Global Product Quality Strategies and provide/ influence strategic direction for New Product Development projects in new or complex areas as 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.
Apply balance of risk, regulatory intent and business needs to come to efficient and effective solutions for improvements in 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, risk and project timing. Review and provide guidance to PD teams for Product Development deliverables to ensure they are completed accurately and efficiently.
Partner with other quality team members to ensure smooth transition of projects to ongoing Cross-functional team management. Provide expertise to and support other Global Product Quality team members as required.
Actively engage, collaborate and build relationships with stakeholders and leaders, including Engineering, QA, RA and other cross functional partners to understand business/department needs, risks and concerns. Build this consideration into strategy planning and proposals to 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 latest quality standards, requirements and best practices while applying them to ResMed processes; provide thought leadership in quality aspects to rest of team / business. Maintain strong knowledge in these areas for software in both medical and adjacent industries.
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
Identify areas and opportunities to improve QMS processes
Keep the management up to date on the Digital Health developments, relevant standards, requirements and best practices while applying them to ResMed processes, and provide training, guidance, interpretation and mentorship as needed to various Engineering, stakeholder, QARA team members. Assist in capability development and upskilling of Product Quality Engineers.
Participate and lead support of internal and external audits within the relevant areas. Participate in investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and 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 for SaMD, AI/ML models, Platform, IoT projects etc.
Provide consultation to end users and process owners with regards to quality data collection, analysis and creation 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 qualifications deemed appropriate for this position.
Significant experience in relevant roles, e.g. 5-8+ years of experience in design quality.
Expert knowledge and experience in applying MDSAP, FDA, MDD/MDR and ISO Quality standards/regulations, including ISO13485, ISO14971 and IEC62304 for software development.
Experience with SaMD (Software as A Medical Device).
Supports processes such as CAPAs, and developing Quality metrics
Demonstrated ability to accomplish goals and embrace change while working with Product Development stakeholders is required:
Strong knowledge of current good design practices for software, applicable design control elements that can be applied for software in medical and non-medical projects.
Real-world experience in leading critical projects in areas of Software product development, design controls, verification & validation, risk management, change control for SaMD or System projects
Experience coordinating issue resolution using a risk-based approach.
Strong analytical and problem-solving skills, with a focus on continuous improvement.
Excellent written, verbal communication and collaboration skills with a strong ability to negotiate and influence
Preferred
Experience with Class I and Class II medical devices, EU MDR, MDDS (Medical Device Database Systems), CDS (Clinical Decision Support) devices.
Project management experience/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 party Audit experience (MDSAP, ISO recertification, FDA QSR audits etc)
Experience implementing new standards/ regulations/ best practices in QMS/ Software development and training cross-functional team members.
Basic understanding of Statistical data analysis for testing.
Applied experience with quality and statistical analysis tools (SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis).
Quality Certification preferred (e.g., ASQ CQE, CSQE, Six Sigma etc.)
Familiarity with EU GDPR, AI laws, other US and International AI regulations/ standards/ guidances would 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.
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!
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