In-Demand Medical device product development engineer Jobs in Sydney Nsw

Senior Quality Assurance Engineer - Audits
ResMed —Sydney NSW
- Full-time
- Management
- Engineering
- Bachelor's degree
Junior Electronics Engineer
Macquarie Medical Systems Pty Ltd —Lilyfield NSW
- $62,337.40 - $80,000.00 a year
- Full-time
- Management
- In-person
- Communication skills
Quick Apply
Senior Quality Design Assurance Engineer
Saluda Medical —Macquarie Park NSW
- Analysis skills
- Presentation skills
- Bachelor's degree
14d
Principal Systems Integration, Verification and Validation Engineer
Cochlear Ltd —Sydney NSW
- Full-time
- Engineering
Design Quality Engineer
Heidi —Sydney NSW
- Full-time
- Hybrid work
- Bachelor's degree
- Communication skills
- Work from home
- Parental leave
Senior Associate - External Manufacturing Quality
Reckitt —Sydney NSW
- Bachelor's degree
- Manufacturing
- Communication skills
- Employee assistance program
- Life insurance
11d
Solutions Engineer, Sydney
Verkada —Sydney NSW
- Engineering
- AWS
- Bachelor's degree
- Commuter assistance
- Health insurance
Technical Services Administrator
Zoll Medical Corporation —St Leonards NSW
- Contract
- Microsoft Word
- CRM software
- Microsoft Excel
Senior Process Engineer
Cochlear Ltd —Sydney NSW
- Full-time
- Engineering
- Bachelor's degree
- In-person
Senior/Principal Machine Learning Engineer - Aus
Harrison.ai —Sydney NSW
- Full-time
- Remote
- Doctoral degree
- Research
- AWS
QA Lead
Heidi —Sydney NSW
- Full-time
- Remote
- AI
- Work from home
- Parental leave
Compliance Specialist - Service and Projects (12-month FTC)
Getinge Australia Pty Ltd —Chatswood NSW
- Contract
- Parental leave
Technical Support Engineer
Verkada —Sydney NSW
- Customer service
- Writing skills
- Engineering
- Commuter assistance
- Health insurance
7d
Senior Systems Engineer
Cochlear Ltd —Sydney NSW
- Full-time
- Engineering
- Agile
- In-person
Senior Design / Design Engineer
ResMed —Sydney NSW
- Full-time
- CAD
- Bachelor's degree
- Leadership
Senior Systems Engineer, Smart Implant Systems
Cochlear Ltd —Sydney NSW
- Full-time
- Engineering
- Agile
- In-person
1d
Software Quality & Validation Specialist
MoleMap Australia & New Zealand —Mascot NSW
- Hybrid work
- Management
- Computer Science
- APIs
Senior Industrial Designer
Capgemini Sogeti —Glebe NSW
- Hybrid work
- CAD
- Bachelor's degree
- Manufacturing
Senior Industrial Designer
Capgemini —Glebe NSW
- Hybrid work
- CAD
- Bachelor's degree
- Manufacturing
Embedded Software Engineering Manager
Cochlear Ltd —Sydney NSW
- Full-time
- Systems design
- Software development
- Agile
1h

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Senior Quality Assurance Engineer - Audits

ResMed -
Sydney NSW

Apply Now

Job Details

Full-time

Qualifications

Management
Engineering
Quality assurance
Bachelor's degree
AI
Communication skills
Internal audits
FDA regulations

Full Job Description

Job Summary

The primary role of the Quality Assurance – Quality Systems function is to ensure that management systems are established and maintained to enable business compliance with multiple regulatory frameworks and support the design, development and manufacture of products that meet customer quality requirements.

The function supports all aspects of the audit program to ensure regulatory compliance, quality best practice, process improvement and the development of supplier quality systems. It provides broad technical support across the business for QA systems and processes, supports and implements significant quality projects, and creates and improves quality and business processes.

Let’s talk about Responsibilities

Prepare a comprehensive internal and supplier audit program that meets business requirements and applicable external regulatory body expectations.
Support the global internal quality auditor program, including mentoring and coaching less-experienced auditors in their internal audit assignments.
Work with business and process stakeholders to effectively implement the audit program and coordinate CAPA investigations with CAPA owners, as required.
Ensure internal audits are conducted and followed up through effective corrective action implementation.
Review audit findings for adequacy and the effectiveness of actions prior to closure.
Project-manage activities required to prepare for external audits and address findings raised during external audits.
Prepare formal responses to external audits for management review prior to submission.
Review quality audit processes, policies and tools on an ongoing basis to ensure they remain relevant and valuable to the business.
Provide management with reports on the status of the audit program, including an assessment of potential business impact.
Develop and implement strategies for the continual improvement of the audit system, aligned with recognised best practice and informed by analysis of specific Resmed needs.
Work with corresponding QA teams in other parts of Resmed to ensure audit systems are aligned and suitable for global deployment, where appropriate.

Let’s talk about Qualifications and Experience

Required (Qualifications/experiences that are an absolute must for the position)

Bachelor’s degree in science or engineering.
Experience with ISO 13485 and 21 CFR Part 820 requirements.
Minimum of 8 years applied professional quality assurance experience , ideally including experience in the medical device industry.
Formal training and experience as a lead auditor for Quality Systems audits.
Knowledge of Quality System requirements and their practical application in medical device manufacturing and development, including but not limited to QMSR , ISO 9001 and ISO 13485 .

Preferred (Qualifications/experiences that are preferred for the position)

Experience in a regulated industry associated with manufacturing or design , including ISO, MDSAP, FDA CFR, EU MDR and TGA requirements .
Knowledge of Environmental Management Systems , including but not limited to ISO 14001.
Experience in conducting supplier audits.
Knowledge and application of Six Sigma, Lean methodologies, 8D and other problem-solving techniques.
Moderate statistical analysis skills and experience applying AI tools or techniques .
Strong listening, verbal, and written communication skills.
Change management skills.
The ability to identify linkages and dependencies between processes.
Ability to think clearly and critically, assess information and evidence , and make informed, timely decisions.
Agility to adapt and respond quickly , with resilience to overcome obstacles.

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! We commit to respond to every applicant.

Apply Now

Refine Your Search

medical device product development engineer jobs in sydney nsw

Senior Quality Assurance Engineer - Audits

Junior Electronics Engineer

Senior Quality Design Assurance Engineer

Principal Systems Integration, Verification and Validation Engineer

Design Quality Engineer

Senior Associate - External Manufacturing Quality

Solutions Engineer, Sydney

Technical Services Administrator

Senior Process Engineer

Senior/Principal Machine Learning Engineer - Aus

QA Lead

Compliance Specialist - Service and Projects (12-month FTC)

Technical Support Engineer

Senior Systems Engineer

Senior Design / Design Engineer

Senior Systems Engineer, Smart Implant Systems

Software Quality & Validation Specialist

Senior Industrial Designer

Senior Industrial Designer

Embedded Software Engineering Manager

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