Quality Engineer
Outstanding opportunity to join a global high-tech business with more than 30 years at the forefront of medical device technology and manufacturing
Summary about this job
Quality Assurance & Control
Company: Ellex Medical Pty Ltd
Location: Adelaide
Work type: Full Time
Salary: n\a
Phone: +61-3-8868-6936
Fax: +61-8-6166-3613
E-mail: n\a
Site: n\a
Detail information about job Quality Engineer. Terms and conditions vacancy
Ellex Medical is a global, high-tech company with more than 30 years in the forefront of medical device technology. From its headquarters in Australia, Ellex designs, manufactures and sells a premium line of medical devices used to diagnose and treat eye disease. We are recognised as the global leader in ophthalmic laser technology and our devices are used by eye surgeons around the world. We have sales offices in the USA, France, Germany, Japan and Australia, and a network of more than 50 distribution partners around the world services other markets.
A fantastic opportunity has arisen for an experienced Quality Engineer to join our Quality Management team in our head office. This role will be responsible for developing, maintaining and improving the quality system in accordance with Ellex Quality and Regulatory requirements. Central to this role is the continuous interface with supply chain, design and manufacturing engineering and production teams.
Other responsibilities include, but are not limited to:
- Plan and direct activities concerned with development, implementation, maintenance, and continuous improvement of our quality system
- Quality planning and process validation to support new product development, design changes product quality improvement, CAPA management, production and process controls, and continuous improvement through the use of statistical techniques and other accepted quality practices
- Training and support employees in quality principles, effective corrective actions, and valid statistical techniques.
- Participate in design or process related changes through ECR change control and ensure design and process requirements have been met. Determine if design reviews/validations have been suitable performed,
- Conduct audits of internal quality systems including process related.
- Improve and maintain risk management processes
- Maintain the Quality Procedure and Work Instruction Training matrix and ensure adherence to the requirements
- Review Manufacturing procedures and test records for suitability for processes and quality acceptance
- Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials and determining investigation where applicable.
- Constantly review the current quality system and recommend / implement improvements as needed.
To be successful in this role, you will have:
- A Diploma or equivalent experience in Engineering or other related profession
- Hold an Internal Auditing Certificate
- 3 to 5+ years of experience in a Quality role within a manufacturing company, ideally 3+ of these within Medical Device Manufacturing
- Extensive knowledge of Quality Management Systems coupled with strong skills in risk management of processes, process validation and process control
- Proven internal auditing experience
- Previous experience in mentoring people
- Strong written and verbal communication skills
- Systematic thinking and problem-solving aptitude
- Exposure and knowledge of Medical Device Regulations and ISO 13485 standard would be highly regarded
If you wish to join a dynamic and growth focused business then please apply. For additional information about Ellex and its products, please visit www.ellex.com
Note: We do not accept unsolicited CV’S from recruitment agencies/third parties.