Quality Manager

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

Job summary

i‑Pharm Consulting is seeking a Quality Manager to ensure products and processes meet regulatory requirements and customer expectations. You will drive continuous improvement, maintain ISO certifications, and lead quality excellence across the organisation.

The role requires strategic leadership in QA, compliance with industry regulations, and collaboration with cross‑functional teams to optimise operations and quality outcomes.

Qualifications

• Experience in regulated industries with medical device and food manufacturing.
• Strong knowledge of ISO 9001, ISO 13485, GMP, and Australian regulations.
• Familiar with ISO 14971 or ISO 31000 and risk management practices.

Responsibilities

• Lead internal and external audits, including ISO surveillance and recertification.
• Monitor QMS performance and drive continuous improvement.
• Ensure QMS documentation per ALCOA+ principles.
• Liaise with regulators, auditors, customers and stakeholders.
• Oversee supplier qualification and quality control for materials.
• Lead cross-functional risk assessments and CAPA actions.

Skills

QMS experience

ISO 9001 / ISO 13485

GMP & regulatory knowledge

Audit management

Root cause analysis / CAPA

People leadership

Stakeholder communication

Lean / Six Sigma

Education

Bachelor's degree in science or engineering

Lead Auditor / Lean Six Sigma cert

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.

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

Qualifications

• 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

Required Skills

• 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