In-Demand Quality compliance director Jobs in Melbourne Vic

Director of Quality
Proton Intelligence Inc. —Clayton VIC
- Full-time
- Management
- Engineering
- Leadership
Quick Apply
2d
Quality Director
The Royal Melbourne Hospital —Melbourne VIC
- Full-time
- Leadership
- Communication skills
Executive Director – Business Services and Sustainability
Jesuit Social Services —Richmond VIC
- Contract
- AI
- Employee assistance program
2d
Director ANZ Operational Transformation
ADP —Cremorne VIC
- Bachelor's degree
- AI
- Business
4d
Australia EHS and Quality Specialist
Carrier —Melbourne VIC
- Full-time
- Hybrid work
- Engineering
- Analysis skills
- HVAC
9d
Director, Specialist Family Violence Services
safe steps —Melbourne VIC
- Full-time
- Organisational skills
- Leadership
- Communication skills
2d
Director of Studies
LCI Education —Collingwood VIC
- Full-time
- Doctoral degree
- Master's degree
- Administrative experience
Quick Apply
Australia EHS and Quality Specialist
Sourceo —Melbourne VIC
- Full-time
- Engineering
- Analysis skills
- HVAC
2d
Director, Specialist Family Violence Services
Safe Steps Family Violence Response Centre —North Melbourne VIC
- Full-time
- Organisational skills
- Leadership
- Communication skills
Quick Apply
1d
Senior Service Delivery Manager Melbourne, Victoria
Bupa —Melbourne VIC
- Management
- Analysis skills
- Financial services
1d
Director, Audit Quality
Victorian Government —Melbourne VIC
- $240,938 - $310,385 a year
- Full-time
- Analysis skills
12d
Centre Director - Relocation to Rockhampton, Queensland
Green Leaves Early Learning Centres —Melbourne VIC
- Full-time
- Supervising experience
- First Aid Certification
- Leadership
- Employee discount
Quick Apply
11d
Senior Advisor, Accessibility & Inclusion
Victorian Government —Melbourne VIC
- $116,413 - $140,849 a year
- Full-time
- Communication skills
8d
Manager – Consulting & Program Delivery
Flexiq Pty Ltd —Melbourne VIC
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick Apply
12d
Project Director
Hickory —Southbank VIC
- Construction experience
- Leadership
- Negotiation
- Parental leave
- Employee assistance program
11d
Test Manager - Contract
TourbillionCX —Melbourne City Centre VIC
- Contract
- Management
- Communication skills
- Negotiation
Program Manager
Victorian Government —Melbourne VIC
- $142,790 - $191,084 a year
- Full-time
- Construction experience
- Leadership
9d
AI Delivery Lead
Online Education Services —Melbourne VIC
- Hybrid work
- Analysis skills
- Agile
- AI
- Health insurance
- Parental leave
Quick Apply
9d
Senior Manager
Victorian Government —Melbourne VIC
- $142,790 - $191,084 a year
- Full-time
- Recruiting
11d
Senior Projects Officer
Victorian Government —Melbourne VIC
- $100,894 - $114,476 a year
- Full-time
- Administrative experience
- Budgeting
3d

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Director of Quality

Proton Intelligence Inc.
Clayton VIC

Quick Apply

Job Details

Full-time
2 days ago

Qualifications

Management
Engineering
Document management
Leadership
Communication skills

Full Job Description

About Proton Intelligence Inc.

Proton Intelligence is developing subcutaneously implantable sensors intended to improve the management of chronic kidney disease and heart failure. Our lead product is a continuous potassium monitoring platform designed to give clinicians and patients earlier, more actionable visibility into changes in potassium levels.

About the role

Proton Intelligence is seeking a senior, hands-on Director of Quality to build, implement and lead a fit-for-purpose, ISO 13485-compliant quality management system as our continuous potassium monitoring products advance through clinical development and toward commercialisation.

This is a foundational leadership role based at our R&D Centre in Clayton, Victoria. You will partner closely with Technical, Clinical, Regulatory, Operations and Executive leaders to make quality a practical part of how the company works. The right person will be comfortable setting strategy, doing the detailed work, coaching a growing team and helping colleagues adopt disciplined regulated-development practices.

WHAT YOU'LL DO

Own Proton's quality strategy, QMS roadmap and operating cadence, including the critical path toward ISO 13485 certification.
Assess current quality processes and documentation, identify compliance gaps and lead a proportionate, risk-based remediation plan aligned with company milestones.
Establish practical quality governance, process ownership, review forums, decision rights, escalation pathways and management review.
Implement and administer an effective electronic quality management system and build robust document-control processes, SOPs, work instructions, templates, forms, registers and controlled records.
Establish and operate fit-for-purpose design controls integrated with product development, including the Design History File, traceability, verification, validation and design transfer.
Partner with Technical and Regulatory teams to keep requirements, risks, standards, claims, changes and submission evidence coherent and ready for review.
Mature core QMS processes including supplier quality, training, nonconformance, deviations, CAPA, equipment and calibration controls, internal audits and quality metrics.
Support Clinical Operations with appropriate quality oversight of study documentation, vendors, training, deviations, data integrity and inspection readiness.
Investigate quality issues to root cause, ensure corrective and preventive actions are effective, and use trends to improve both the QMS and underlying operations.
Deliver practical quality training, coach colleagues, manage specialist providers as needed and build the plan for future quality-team capacity as Proton scales.

WHAT WE'RE LOOKING FOR

10+ years of progressively responsible quality experience in medical devices, diagnostics, connected health or a related regulated-product environment.
Demonstrated success building, materially remediating or scaling a medical-device QMS and leading an organisation through ISO 13485 certification or recertification.
Deep applied knowledge of ISO 13485, document control, design controls, risk management, supplier quality, training, nonconformance, CAPA, audits and management review.
Hands-on experience implementing and administering an electronic quality management system.
Sound judgement in assessing imperfect legacy documentation and compliance debt, making proportionate risk-based decisions and sequencing remediation without paralysing product development.
Strong change-leadership, coaching and influencing skills, including experience helping technically capable teams adopt consistent regulated ways of working.
Ability to work across hardware, software and data, clinical, regulatory, operations, manufacturing and executive stakeholders.
Excellent written and verbal communication skills and a willingness to operate as a hands-on first quality leader while building durable systems and developing others.
A degree in engineering, life sciences, quality or a related discipline is required; advanced quality or regulatory certification is preferred.

WHAT SUCCESS LOOKS LIKE

In your first 90 days, you will assess Proton's current quality system and establish an agreed, risk-based roadmap for closing critical gaps and progressing toward ISO 13485 certification.
During your first year, you will embed the electronic quality system and core QMS processes, strengthen design controls and quality records, establish a current and traceable Design History File, and close or formally control the highest-risk legacy gaps.
Longer term, you will mature the system toward audit readiness, build sustainable quality capability across the company and reduce dependence on the Quality lead for routine compliance.

Quick Apply

Refine Your Search

quality compliance director jobs in melbourne vic

Director of Quality

Quality Director

Executive Director – Business Services and Sustainability

Director ANZ Operational Transformation

Australia EHS and Quality Specialist

Director, Specialist Family Violence Services

Director of Studies

Australia EHS and Quality Specialist

Director, Specialist Family Violence Services

Senior Service Delivery Manager Melbourne, Victoria

Director, Audit Quality

Centre Director - Relocation to Rockhampton, Queensland

Senior Advisor, Accessibility & Inclusion

Manager – Consulting & Program Delivery

Project Director

Test Manager - Contract

Program Manager

AI Delivery Lead

Senior Manager

Senior Projects Officer

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