My client is an industry leader that has been servicing the Australian Healthcare Industry for four decades. Products they manufacture and supply include custom medical devices and their overall portfolio spans across 3000 different products!
With a state-of-the-art cleanroom and multiple sites across Melbourne, their talented staff is made up of purchasing and procurement professionals, product management, manufacturing, regulatory affairs, and quality assurance.
Purpose and general description of the role:
The Supplier Quality Engineer supports the Quality Department by working across all areas of supplier quality management - from supplier approval, evaluation and performance, to ongoing development and reviews.
The Successful Candidate will be a dedicated resource that monitors supplier services and quality, ensuring that supply continuity and effectiveness is consistently met.
Other duties will include managing customer complaints and assisting with investigations, managing CAPA system, conducting supplier & internal audits, participating in risk management activities and approving product release.
Duties of the role include (but are not limited to):
- Assisting with building, implementing and maintaining a supplier quality assurance framework
- Liaising directly with new and existing suppliers - developing and maintaining relationships, maintaining supplier agreements, collaborating with suppliers to improve standards and methods for processing, testing and validating materials and products
- The Supplier Quality Engineer will be the subject matter expert with relevant technical and quality standards
- Conducting new material evaluations (and assisting with developing appropriate specifications) and qualification
- Identifying improvement opportunities and on-going performance management of external suppliers - conducting reviews and approving suppliers
- Managing customer complaints and assisting with investigations
- Managing CAPA system
- Conducting supplier and internal audits
- Participate in risk management activities
- Approving product release
The Successful Candidate will possess the following:
- Relevant tertiary qualifications in science or engineering
- Minimum 3 years experience working in a similar role within a medical device manufacturing environment (strong understanding of GMP and ISO 13485 standards along with TGA regulations)
- Excellent experience dealing with external suppliers and carrying-out effective supplier management, reviews and approval
- Ability to interpret and evaluate technical specifications, along with mechanical drawings in for products and processes
- Project management ability and experience
- High level of analytical ability and great attention to detail
- Excellent communication skills - Both written and verbal, along with outstanding interpersonal skills
Benefits and perks:
- Fantastic company culture, one that has a collaborative work environment and a culturally diverse group of staff
- My client offers their employees a paid lunch break, which is accrued to entitle them to an RDO (rostered day off) per month
- My client generously provides annual leave loading for all staff
Please send your application to firstname.lastname@example.org with your cover letter and resume in Word format.
Questions can be referred to Leah Creswick at Fuse Recruitment on 0478 193 170.