Quailty Manager

i‑Pharm Consulting; Dubbo; On-site; AUD 120,000 - 180,000; Full time

Job summary

i‑Pharm Consulting in Dubbo, NSW, is seeking a Quality Manager to ensure products, services, and processes meet regulatory standards and customer expectations. You will lead the quality management system, drive continuous improvement, and sustain ISO certifications across the organisation.

The role requires strong audit experience, risk management, and people leadership to mentor teams and coordinate with regulators, customers, and suppliers in a fast-moving life sciences environment.

Qualifications

• Proven experience managing QMS in regulated industries (medical devices and food manufacturing).
• Deep knowledge of ISO 9001, ISO 13485, GMP and Australian regulatory requirements.
• Experience with ISO 14971 or ISO 31000 risk management.
• Strong audits experience, including internal and supplier/customer audits.
• Lean Manufacturing or Lean Six Sigma, or similar improvement methodologies.
• Bachelor's degree in science, engineering, or related field.
• Certified Lead Auditor for ISO 9001 or ISO 13485 or Lean Six Sigma.

Responsibilities

• Monitor QMS performance through data analysis and continuous improvement.
• Establish, implement, maintain, and improve the QMS.
• Lead internal and external audits including ISO surveillance.
• Coordinate CAPA actions and root-cause analysis.
• Liaise with regulators, auditors, customers and stakeholders.
• Oversee supplier quality and raw material controls.
• Promote ALCOA+ data integrity and regulatory compliance.

Skills

QMS management

Auditing

CAPA

Lean Six Sigma

Regulatory knowledge

Leadership

Stakeholder comms

Education

Bachelor's degree in science/engineering/related

Lead Auditor certification (ISO 9001/13485)

Tools

ALCOA+

GMP

ISO 9001/13485 standards

Job description

A specialist provider of animal-derived biological materials to the global healthcare and life sciences industries. Headquartered in Dubbo, NSW, with operations across Australia and New Zealand, the company supplies materials used in medical devices, pharmaceuticals, vaccines, diagnostics and research.

Working closely with international customers, the business develops tailored processing and supply chain solutions, with a strong focus on quality, traceability and meeting customer and regulatory requirements.

About the role

The Quality Manager is responsible for ensuring that the organisation's products, services, and internal processes meet all regulatory requirements, quality standards, and customer expectations. This role drives continuous improvement in quality assurance and compliance across the organisation, maintaining ISO certifications, and fostering a culture of quality excellence. The Quality Manager provides strategic leadership in quality management, ensuring that the organisation operates efficiently and in compliance with industry regulations and best practices.

Key responsibilities

• Monitor the performance and effectiveness of the QMS through the analyses of data and recommending needs for improvement
• Ensure that the Quality Management System (QMS) is established, implemented, maintained, and continually improved
• Ensure processes needed for QMS are documented, following ALCOA+ principles
• Promote awareness of applicable regulatory and QMS requirements throughout the organisation
• Align, incorporate and execute Quality Management Plans, and act as the control for these plans
• Act as the liaison between the organisation and regulatory bodies, auditors, customers and stakeholders for quality and customer regulatory activities
• Lead internal and external audits, including ISO surveillance and recertification, supplier, and customer inspections
• Lead cross-functional risk assessments and ensure product quality risks are mitigated (ALARP)
• Assess the viability and effectiveness of corrective and preventive actions, and assign actions based on risk priority
• Oversee supplier qualification and ongoing quality control for raw materials and outsourced services

About you

• Proven experience managing QMS in a regulated industry, with medical device and food manufacturing experience
• In-depth understanding of ISO 9001, ISO 13485, GMP, and Australian regulatory requirements
• In-depth understanding of ISO 14971 or ISO 31000 and applying best practice
• Demonstrated ability to manage internal and external audits, ensuring adherence to industry best practices
• Experience in leading root cause analysis using structured methodologies and effective CAPA implementation
• Strong people management skills with experience in mentoring, coaching, and developing high-performing teams
• Ability to effectively communicate with internal and external stakeholders
• Experience in Lean Manufacturing or Lean Six Sigma, or other quality improvement methodologies
• Bachelor's degree in science, Engineering, or a related field
• Certified Lead Auditor for ISO 9001 or ISO 13485, Lean Manufacturing or Lean Six Sigma certification, or equivalent industry qualifications