Quality Assurance Leader – ISO, Audits & Compliance

i‑Pharm Consulting; Dubbo; Presencial; AUD 120 000 - 180 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

QMS experience

ISO 9001 / ISO 13485

GMP & regulatory knowledge

Audit management

Root cause analysis / CAPA

People leadership

Stakeholder communication

Lean / Six Sigma

Formação académica

Bachelor's degree in science or engineering

Lead Auditor / Lean Six Sigma cert

Descrição da oferta de emprego

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.