In-Demand Senior quality engineer Jobs in Silverwater, Nsw

Senior Quality Assurance Engineer - Audits
ResMed —Sydney NSW
- Full-time
- Management
- Engineering
- Bachelor's degree
Senior Quality Design Assurance Engineer
Saluda Medical —Macquarie Park NSW
- Analysis skills
- Presentation skills
- Bachelor's degree
Senior Process Engineer – Water Treatment
Stantec —Sydney NSW
- Part-time
- Writing skills
- Communication skills
- Negotiation
- Work from home
- Employee assistance program
Senior Structural Engineer
Ausgrid —Haymarket NSW
- $197,247 a year
- Full-time
- Hybrid work
- Construction experience
- Communication skills
- Parental leave
6d
Senior/Principal Machine Learning Engineer - Aus
Harrison.ai —Sydney NSW
- Full-time
- Remote
- Doctoral degree
- Research
- AWS
Senior Solutions Implementation Engineer
Landis+Gyr —Mascot NSW
- Full-time
- Remote
- Engineering
- Work from home
- Parental leave
Senior Maritime Engineer
Royal HaskoningDHV —North Sydney NSW
- Hybrid work
- Communication skills
22h
Senior Structural Engineer
Taylor Thomson Whitting —North Sydney NSW
- $110,000 - $115,000 a year
- Full-time
- Management
- Engineering
- In-person
Quick Apply
11d
Senior Risk Engineer
WTW —Sydney NSW
- Full-time
- Engineering
- Communication skills
- Analytics
Senior / Lead Analytics Engineer
Insight Timer —Sydney NSW
- Full-time
- Remote
- Master's degree
- SQL
- Bachelor's degree
Quick Apply
Senior Research Engineer
Canon —Sydney NSW
- Doctoral degree
- Research
- Presentation skills
- Free parking
7d
Senior Water and Sewer Engineer
Northrop Consulting Engineers —Sydney NSW
- Full-time
- Hybrid work
- Engineering
- Business development
- Parental leave
- Employee assistance program
Senior Structural Engineer
KBR —Sydney NSW
- Full-time
- Engineering
- Health insurance
- Annual leave
Senior Quality Assurance Engineer - Recently Acquired & Scaling FinTech
The Argyle Network —Sydney NSW
- $120,000 a year
- Full-time
- Computer Science
- Analysis skills
- Bachelor's degree
Senior Project Engineer
Hindmarsh —Sydney NSW
- Full-time
- Construction experience
- Leadership
- Communication skills
- Employee discount
Senior Project Engineer
The Arnott's Group —Huntingwood NSW
- Budgeting
- Parental leave
- Gym membership
Senior Mobile Engineer
Kantoko —Surry Hills NSW
- Full-time
- Hybrid work
- APIs
Quick Apply
Senior Structural Engineer
AtkinsRéalis —Sydney NSW
- Full-time
- Hybrid work
- Bachelor's degree
- In-person
Senior Structural Engineer (NSQEP)
AECOM —Sydney NSW
- Full-time
- Hybrid work
- Research
- Master's degree
- Bachelor's degree
Senior Intergration Engineer
Macquarie Group Limited —Sydney NSW
- Full-time
- Hybrid work
- APIs
- Agile
- AI
- Annual leave
- Work from home
1d

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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

senior quality engineer jobs in silverwater, nsw

Senior Quality Assurance Engineer - Audits

Senior Quality Design Assurance Engineer

Senior Process Engineer – Water Treatment

Senior Structural Engineer

Senior/Principal Machine Learning Engineer - Aus

Senior Solutions Implementation Engineer

Senior Maritime Engineer

Senior Structural Engineer

Senior Risk Engineer

Senior / Lead Analytics Engineer

Senior Research Engineer

Senior Water and Sewer Engineer

Senior Structural Engineer

Senior Quality Assurance Engineer - Recently Acquired & Scaling FinTech

Senior Project Engineer

Senior Project Engineer

Senior Mobile Engineer

Senior Structural Engineer

Senior Structural Engineer (NSQEP)

Senior Intergration Engineer

I want to receive the latest job alert for senior quality engineer in silverwater, nsw

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