In-Demand Iso lead auditor jobs Jobs in Sydney Nsw

Senior Quality Assurance Engineer - Audits
ResMed —Sydney NSW
- Full-time
- Management
- Engineering
- Bachelor's degree
10d
HSEQ Advisor
SYSTRA —Sydney NSW
- Contract
- Management
- Engineering
- Bachelor's degree
- Employee assistance program
EHS Advisor Role (Onsite) (Full time, two-year fixed term) (Program Implementation)
Siemens Energy —Sydney NSW
- Full-time
- Hybrid work
- CPR Certification
- Bachelor's degree
- First Aid Certification
VP, Head of Technology and Information Security, DBS Australia (Sydney)
DBS Bank —Sydney NSW
- Full-time
- Management
- Computer Science
- Master's degree
National Operations Manager (Audit & Certifications)
SGS —Alexandria NSW
- Full-time
- Management
- Microsoft Office
- Organisational skills
- Parental leave
Quick Apply
QA/QC Officer
Griffin Marine Services —Sydney NSW
- Full-time
- Engineering
- Welding
- Communication skills
Quick Apply
Safety and Compliance Coordinator
PMY Group —Sydney NSW
- Remote
- Microsoft Office
- Communication skills
QHSE Advisor | Western Sydney NSW
CEVALogistics —Sydney NSW
- Full-time
- Hybrid work
- Management
- Communication skills
- Disability insurance
- Parental leave
WHS Consultant
Marsh —Sydney NSW
- Full-time
- Hybrid work
- Management
- Communication skills
Manager - Tech Risk Assurance
BDO —Sydney NSW
- Full-time
- Organisational skills
- Health insurance
- On-the-job training
Environment, Quality, Health and Safety (EQS) Lead - Turnkey Projects
Siemens Energy —Sydney NSW
- Full-time
- Hybrid work
- Bachelor's degree
- Construction experience
Business Continuity Program Manager
NEXTDC —Sydney NSW
- Full-time
- Hybrid work
- Financial services
Quick Apply
2d
Quality Control Manager - Electronics Manufacturing
Advanced Navigation —Sydney NSW
- Bachelor's degree
- Software development
- Manufacturing
Head of IT Resilience and Cybersecurity
Transdev —Sydney NSW
- Full-time
- Analysis skills
- Communication skills
1d
Quality Engineer
Daikin —Chipping Norton NSW
- Full-time
- Engineering
- Bachelor's degree
- HVAC
- On-the-job training
4h
Cyber Risk and Governance Analyst - EVT Head Office
EVT Group —Sydney NSW
- Full-time
- Azure
- AWS
- No degree
- Parental leave
Safety Manager
Eirecon Constructions —Sydney NSW
- Full-time
- Analysis skills
- Construction experience
- Leadership
21h
Principal Assurance
Evolution Mining —Sydney NSW
- Management
- Analysis skills
- Communication skills
- Life insurance
- Referral program
Senior Security Consultant
NCC Group —Sydney NSW
- Full-time
- Hybrid work
- Computer Science
- Bachelor's degree
- Communication skills
- Annual leave
- Employee assistance program
Quick Apply
HSEQ & Facilities Officer
Teletrac Navman —Sydney NSW
- Communication skills

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iso lead auditor jobs jobs near sydney nsw

Senior Quality Assurance Engineer - Audits

ResMed -
Sydney NSW

Apply Now

Job Details

Full-time
10 days ago

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

iso lead auditor jobs jobs in sydney nsw

Senior Quality Assurance Engineer - Audits

HSEQ Advisor

EHS Advisor Role (Onsite) (Full time, two-year fixed term) (Program Implementation)

VP, Head of Technology and Information Security, DBS Australia (Sydney)

National Operations Manager (Audit & Certifications)

QA/QC Officer

Safety and Compliance Coordinator

QHSE Advisor | Western Sydney NSW

WHS Consultant

Manager - Tech Risk Assurance

Environment, Quality, Health and Safety (EQS) Lead - Turnkey Projects

Business Continuity Program Manager

Quality Control Manager - Electronics Manufacturing

Head of IT Resilience and Cybersecurity

Quality Engineer

Cyber Risk and Governance Analyst - EVT Head Office

Safety Manager

Principal Assurance

Senior Security Consultant

HSEQ & Facilities Officer

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