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Form of workAbout:
Working with an innovative company across a range of medical device technologies.
The company is expanding to bring to market products that will be exported to Europe and the USA from Sydney.
As an accredited company to ISO 13485, there is a continual development investing into new technologies and staff training for the design and manufacture of medical devices. This is a role where the right person will enjoy being able to work across a range of supplied technologies both locally and from Europe.
Description of the role.
It is intended that the Quality Associate would be across all Quality Assurance & QC activities. The incumbent will report to the Quality Manager and work with related internal teams and projects. Our technologies cross some areas of pharma and medical devices where we will be planning and developing validations for sterilisation, first article release and also ongoing batch releases.
My client has in house processes for Sterilisation of devices and has registration with the FDA for our manufacturing processes.
RESPONSIBILITIES AND DUTIES
As a general guide:
- Quality Compliance Area; Internal Audit Program, Documentation, Sterility Assurance, Quality Assurance & Control in manufacturing and Product Releases. Also, involvement related to compliance activities in the Validation Program.
- Participate with Quality Assurance and Regulatory Compliance Planning and Quality Objectives.
- Involvement with external audits from Regulatory Agencies/ Notified Bodies/ Customer inspections.
- Involvement the Internal Audit Program of departments across the company compliance to regulatory requirements.
- Involvement in supplier audits of critical suppliers.
- Undertake Corrective and Preventive Actions (CAPA) so that they are properly initiated whenever required, ensure adequate investigations and actions are completed in a timely manner, and make sure actions effectively correct/prevent future related issues.
- Perform Customer Complaint investigations so that they can be translated into product and process specifications.
- Conduct trend analysis of delegated Quality Indexes within the facility so that any potential CAPAs can be identified through review of all applicable systems.
- Assist in developing manufacturing processes and customer projects assuring compliance of operations and products to meet specifications and requirements.
- Participates in new product development/design control as needed. Other duties may be assigned, as required
QUALIFICATIONS
- Degree qualified or higher in a related Science, Chemical, Aerospace, Bio Medical Quality systems field.
EXPERIENCE
- Quality experience in a Medical Devices manufacturing or startup environment.
- Working knowledge of standards such as ISO 13485, 21 CFR 820, Therapeutic Goods (Medical Devices) Regulations and other applicable standards.
- Experience in working in ISO class 7 cleanrooms.
- English with strong written and oral communication skills.
- Working knowledge of Continuous Improvement Tools and Process validation experience.
- Computer Literate use of statistical programs
- Must have considerable foresight and planning abilities in order to achieve required objectives.
- Capability for analytical and strategic processes.
- Team oriented skills for problem resolution and implementation of projects.
- Problem solving - logical person.
Please apply via the link.
