Lead Software Quality Assurance Engineer
Job no: 613509
Work type: Permanent
Categories: IT, Quality & Regulatory, Oceania, People Manager
Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help people hear and be heard.
Are you a methodical problem solver with strong influencing skills? Join Cochlear as a Lead Software Quality Assurance Engineer! This is an excellent role where you will be responsible for all aspects of quality control and regulatory requirements of software projects across R&D, IT and Manufacturing. This is a fantastic opportunity for you to think at a range of levels (from high-level risk down to fine details) to ensure Software projects are conducted in accordance with approved procedures and regulatory standards, and that Cochlear’s products are developed to be safe and satisfy customer needs.
You will be responsible for…
- Working with team members throughout the entire Software Development Life Cycle (SDLC) to ensure compliant implementation of software for medical devices; health records; manufacturing equipment; and systems supporting quality management.
- Leading Software Validation activities which include ensuring that R&D, IT, and Manufacturing teams follow approved processes for creating documentation; performing Verification and Validation; and responding to software complaints and anomalies (e.g. bug lists)
- Reviewing and providing guidance on software testing against applicable process requirements
- Ensuring adequate review of all Software version control, release, and archiving procedures across the business
- Supporting risk/hazard/security analysis for Software-related Projects, as an independent reviewer.
- Enable quick and appropriate resolution of non-conformances and CAPAs, including confirmation that supporting documentation is thorough and “audit ready”.
- Lead training for Software-related groups across the business to ensure that personnel are competent in the execution of all quality operational processes supporting R&D, IT, and Manufacturing and to ensure outputs are “audit ready” at any time.
- Identify, initiate, and implement improvements to QMS processes, procedures, and practices particularly in the areas of Software Product Development, V&V, and IT CSV.
- Provide technical management, thought leadership and stakeholder alignment across key areas of the business related to Software Quality.
- Engineering or computer science degree (electrical / computer engineering or software discipline preferred)
- Experience as a quality engineer in regulated software product development projects and software validation processes (7+ years)
- Experience with ISO 13485, ISO 14971, IEC 62304, and Cybersecurity / Data Integrity
- Experience in software development methodologies such as Agile and Scrum
- Experience in projects from inception through to launch and continued support to software life cycle.
- Knowledge of 21 CFR Part 11, MDCG 2019-16, IEC 82304 compliance
- Knowledge of ISO 9001/ ISO 27001 (FDA QSR and cGMP knowledge also an advantage)
- Statistical software skills an advantage
Developmental Value of this role:
This is a brilliant opportunity to join an international, multilingual environment and establish an operational network with Cochlear. You will contribute to the Quality and Regulatory strategic direction towards consistency, standardisation and compliance whilst supporting agility, automation and innovation. Cochlear provides working opportunities and development with other Cochlear regions and the ability to learn from working in a wide range of departments of the organisation.
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
At Cochlear we value and welcome the unique contributions, perspectives, experiences and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.
Advertised: AUS Eastern Standard Time
Anticpated Application Closing: AUS Eastern Daylight Time
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