Make product dispositions as and when required. Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned.
Prepare and update documentation such as Work Instructions, Product Routings (CHR’s), Visual Standards etc. as required.
Prepare Engineering Change Orders (ECO’s). Obtain the necessary approvals and where necessary implement on the document control system.
Perform inspections on product (incoming, in-process and final) as required. This may arise due to product quality investigations, incoming inspection capacity etc.
Prepare process data such as yield, output rates, No. of NCR’s etc.
Perform First Article Inspections as required.
Raise Non-Conformance Reports and ensure associated product is segregated, oversee that NCR’s are closed out in a timely manner.
Oversee the execution of validation activity as required.
Carry out scheduled audits (Internal, Standard Work, out of the box etc.)
Participate in improvement activities, including Kaizen events.
Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
Qualifications arrow_right
Diploma qualification Quality or a related discipline Or significant relevant experience in a quality assurance role within the Medical Device Industry.
A minimum of 3 years’ experience in a similar Quality related role in the Medical Device / Components industry.
Thorough knowledge of Freudenberg Medical products and processes.
Must be able to make product dispositions decisions.
Excellent attention to detail.
Good communication skills both verbal and written.
