AddressAbout
Our client is an ASX-listed company operating in the healthcare industry.
They are looking for a Quality Assurance Manager experienced in Medical Device industry. This person who will be responsible for leading and coordinating the analysis of business processes and procedures to maintain continuous quality assurance throughout the organisation.
Responsibilities And Duties
- Ensure that the Product Process requirements are effectively established and efficiently maintained; reporting on issues relating to Products and Environments.
- Coordinate the cleanroom team and resolve Process or technical issues that arise in the transfer of products from design to the cleanroom team and release by Quality.
- Train operators and interns in the standards of ISO13485 and ISO14971 (risk assessments)
- Develop processes within the team that are compliant to standards for medical devices ISO13485.
- Engage and handle appropriate Corrective and Preventive Actions (CAPA) and internal audits.
- Review and approve production qualifications and validation protocol Preparing the technical reports for new processes being setup in production.
- Assist in developing manufacturing processes and customer projects assuring compliance of operations and products to meet specifications and requirement.
- Participates in new product development/design control as needed.
- Other duties may be assigned, as required.
Qualifications
- Quality Engineer, Biomedical Engineering - Bachelor Science or related Science field.
Experience And Qualifications
- At least Five (5) years of Post Graduate experience in a regulated industry of Medical Devices manufacturing environment
- Proficient in regulations such as ISO 13485, (Medical Devices) Regulations and applicable standards such as ISO14971, ISO11135 or ISO11137
- English with strong written and oral communication skills
- Working knowledge of Process validation
- Computer Literate use of statistical programs
- Capability for analytical and strategic processes
- Team oriented skills for problem resolution and implementation of projects
- Attention to detail, meticulous accuracy with written and numerical work
- Problem solving - logical person
- Strong interpersonal skills for a management role
