Our client is an outstanding, innovative developer of a variety of medical devices. In response to the current Covid-19 crisis, they are currently working on an important and exciting product development and manufacturing project. Additional staffing resources are required to assist, and due to the urgent and complex nature of this project, we are seeking applications from candidates with proven experience working in a medical device manufacturing environment.
The Quality Assurance Associate will assist with managing the company's overall QMS based on ISO 13485 and other standards relevant to the design, development, testing, auditing and marketing of PI products. The Quality Assurance Associate will also help ensure that manufacturing activities on the floor are being carried out in a compliant manner.
Duties of the role include (but are not limited to):
- Evaluation and investigation of customer complaints, non-conformances and CAPA
- Maintenance and archiving document control procedures and training records
- Identifying continuous improvement opportunity for the QMS
- Improving and maintaining the Tool and Process Validation requirements at PI
- Assisting the broader PI team with carious compliance requirements such as GDPR, Electronic Records, RoHS, REACH and internal audits
The Successful Candidate will possess:
- Tertiary qualification in science or engineering
- Minimum 3 years quality assurance experience in a regulated industry
- Experience in handling customer complaints, CAPA and non-conformances
- Experience in quality documentation and internal audits
- Familiarity with the application of US FDA 21 CFT part 820 and ISO 13485
- Knowledge of ISO 14971, general risk processes and Tool and Process Validation an advantage
- Excellent written and verbal communication skills
- High attention to detail
Our client boasts an amazing work environment - One where diversity, innovation, openness and collaboration are all strong parts of their culture.
Applications in Word Format will only be considered (No PDF Documents please).
Questions can be directed to Leah Creswick at Fuse Recruitment on 0478 193 170.