Schott Minifab is a global leader in the development and manufacture of custom medical POC diagnostic devices. Based in the Eastern Suburbs of Melbourne in a state-of-the-art facility, Minifab is a dynamic company comprised of outstanding professionals, working together to achieve a common goal, and whilst doing so daring to Think Big.
Scott Minifab is currently recruiting for an outstanding Quality Specialist to join the team on a permanent full-time basis.
Candidates with experience working with a medical device manufacturing company will be highly regarded.
This position reports to the Quality Manager, responsible for oversite of GMP systems such as Deviations, Training, CAPA, Change Control, and Product Quality Assurance. This position will support the site's execution of and compliance to company policies, GMP regulations & ISO 13485/9001 requirements.
Quality Specialist Responsibilities:
- Lead activities to ensure quality and compliance within the manufacturing and development environment
- Assist in QMS activities including but not limited to, conducting internal audits, managing documentation control, CAPA, investigations, supplier quality management, training, quality testing & control
- Support site audit and inspections (Client and other regulatory body inspections)
- Support introduction of new products into the QMS manufacturing space -qualification and validation activities, document writing, training, etc.
- Lot release of manufactured medical device components
- Identifying and resolving workflow and production issues
- Ensuring that standards and safety regulations are observed
- Addressing and discussing issues and proposed solutions with superiors
- Actively participating and leading QMS continuous improvement projects
- Actively engaging & building strong relationships with cross functional stakeholders for process improvements & to implement strong quality culture mindset
Essential Skills and requirements:
- Science degree or equivalent
- Minimum 5 years working in a Quality role within the medical device or pharmaceutical manufacturing industry (or similar)
- Regulatory experience related to IVDs / medical devices
- Good understanding of GMP, preferably related to medical devices / ISO13485 / ISO9001 requirements
- Experienced in the implementation and use of electronic quality systems (preferred)
- Ability to educate and motivate people to understand and comply to quality requirements
- Ability to translate quality requirements into day to day actions across manufacturing and design
- Ability to work autonomously in a fast-paced environment, across multiple projects and meet deadlines / project deliverables
- Be a team member, supportive of goals of the Quality team and the wider Schott Minifab team
- Awareness and acknowledgement of wider implications of quality across multiple business areas
- Experienced user of Microsoft suite of products
If your skills and experience match the above criteria, then please apply with your CV and covering letter in Word Format.
Questions can be directed to Jaquline Farag Fuse Recruitment Melbourne on 0411 832 205.