SCHOTT MINIFAB is the world’s #1 for custom development and contract manufacture of ISO 13485 certified polymer consumables for diagnostics and life science applications.
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 combined with our unique technologies 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.
Our Melbourne based facility is seeking 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.
This is your chance to join a rapidly growing multinational medical devices company working on the leading edge of medical diagnostics and life-science.
Reporting directly to: Head of Quality
Essential Skills and Requirements:
- 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.
- Experience in MFG design transfer/ NPI
- Experience in process Validation(IQ/OQ/PQ)
- Experience in Product & Design FMEA
- Experience in Project Mgmt/ Lean MFG mgmt
Key Responsibilities and Deliverables:
The responsibilities of this role are (but not limited to):
- 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 mfg 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.
Candidates with experience working in a Medical device; Semiconductors; Bioscience manufacturing background is preferred.