SCHOTT MINIFAB is a global leader experienced in transforming client's concepts into commercially successful products. Our exceptional in-house design, bioscience and engineering teams combine with our unique technologies to create microfluidic products designed for manufacture. All this is backed by our unique manufacturing capability, designed to rapidly scale from pilot line quantities all the way to high volume automated production.
SCHOTT MINIFAB is currently recruiting for a skilled & driven Quality Engineer to join the team on a permanent full-time basis. Reporting to the Head of Quality, you will be responsible for ensuring teams across the business are adopting appropriate quality practices. The aim is to continually improve both the way we work and the processes we develop whilst incorporating agility and compliance.
Accountability & Responsibilities:
- Lead & support NPI, MFG design transfer, qualification & validation project activities.
- Lead & Support QMS projects: CAPA, NC Mgmt., Change management - CCR/ECR, and Product Lifecycle Management
- Lead supplier quality management program and support procurement team in supplier selection based on risk methodology
- Support the development of the technical training framework for more efficient and effective project delivery into manufacturing space
- Actively engage & build strong relationships with cross functional stakeholders for process improvements & to implement strong quality growth culture mindset
- Lead and facilitate Continuous Improvement initiatives to drive performance improvement.
- Develop and update SOP in accordance with the product/client specifications and Quality requirements within the Quality Systems framework
- Support delivery teams through the deployment of Quality Strategy, Management Systems, Process controls, capability building, continuous improvement activities and embedding best practices
- Support efforts to drive down the Cost of Poor Quality (COPQ), deviations and design transfers
- Ensure that safety standards and regulations are observed
- A relevant degree in Engineering/ Science Discipline (Manufacturing, Mechanical, Electronics, Automation, Biotechnology)
- Minimum 5 years' experience in a similar role
- Ability to think strategically, to work autonomously in a fast-paced environment across multiple projects to meet project deliverables.
- Facilitation of continuous improvement initiatives to improve & drive quality growth culture
- Ability to work collaboratively and influence all levels of personnel
- Ability to translate quality requirements into day-to-day actions across manufacturing and design and development business units
- ISO13485, ISO9001, FDA regulatory experience
- MFG design transfer/ NPI
- Process Validation (IQ/OQ/PQ)
- Product & Design FMEA
- Project management / Lean manufacturing experience
- Operation & supply chain management
If your skills and experience match the above criteria, then please apply with your CV in Word Format.
Questions can be directed to Jaquline Farag Fuse Recruitment Melbourne on 0411 832 205.