Quality & Process Engineer - Medical Devices

Konnecting; Sydney; On-site; AUD 72,000 - 88,000; Full time

Job summary

Konnecting is seeking an Industrial Engineer to improve manufacturing efficiency, quality and compliance. You will analyze production workflows, resolve quality issues and ensure ISO 9001 and, where applicable, ISO 13485 requirements are met across production, quality and engineering teams.

You will lead investigations into non-conformances, develop CAPA plans, and support new product and process qualification while tracking key metrics like yield and on-time delivery.

Qualifications

• Bachelor's degree in Industrial Engineering or closely related discipline.
• At least 1 year of quality or industrial engineering experience in manufacturing.
• Working knowledge of ISO 9001 quality management systems and controlled documentation.
• Experience with non-conformance reporting, root cause analysis and corrective actions.
• Ability to interpret technical drawings and dimensional specifications.
• Clear written and spoken English for reports and procedures.

Responsibilities

• Analyze production workflows, cycles times, layouts and resources to identify bottlenecks and waste.
• Apply Lean and Six Sigma tools to recommend and implement improvements.
• Develop and update work instructions, process flows and SOPs.
• Define inspection criteria and in-process and final inspection plans.
• Lead investigations into non-conformances and implement CAPA.
• Maintain quality documentation and support audits.
• Support qualification and validation of new products and production lines.
• Develop and track metrics like yield, scrap, rework and on-time delivery.
• Train production staff on new procedures and promote WHS compliance.

Skills

ISO 9001 knowledge

Non-conformance reporting

Root cause analysis

Corrective actions

Interpret technical drawings

English communication

Education

Bachelor's degree in Industrial Engineering

Tools

OGP measurement systems

Job description

Konnecting is seeking an Industrial Engineer to improve manufacturing efficiency, quality and compliance. You will analyze production workflows, resolve quality issues and ensure ISO 9001 and, where applicable, ISO 13485 requirements are met across production, quality and engineering teams.

You will lead investigations into non-conformances, develop CAPA plans, and support new product and process qualification while tracking key metrics like yield and on-time delivery.