Linear Medical Quality Assurance Coordinator

Summary about this job

Detail information about job Linear Medical Quality Assurance Coordinator. Terms and conditions vacancy

An exciting opportunity exists to join a dynamic and results oriented team of successful professionals and to be part of an innovative company, experiencing phenomenal growth. As a member of the Ramsay Health Care family of companies, Linear Medical is a wholly-owned subsidiary driven by dedication to product development, customer focus and organisational excellence. Linear Medical primarily functions as the developer, sponsor, manufacturer and supplier of high quality medical consumables to the Healthcare Industry.

We have a vacancy for an enthusiastic and driven Quality Assurance Coordinator who will be based in our Macquarie Park office, Sydney.

Working closely with the Regulatory Affairs Coordinator, this is an exciting opportunity to take on a role where your integrity, attention to detail, excellent relationship building skills and regulatory affairs knowledge will drive your success. Reporting to the Head of Operations, this role is responsible for ensuring administrative compliance of Linear Medical products to regulatory authorities and maintenance of our Quality Management System.

To be successful in this role we are ideally looking for someone who has held a similar quality assurance role. You’ll have a focus on continuous improvement and able to demonstrate good time management and organisational ability as well as showing experience in negotiating and prioritising competing work requirements. You’ll also be a proactive individual, who has initiative and is able to work autonomously and take ownership and responsibility for the delivery of outcomes.

Responsibilities

• Maintain compliance to ISO 13485 by managing and maintaining the Quality Management System
• Author and review the Quality Manual and supporting standard operating procedures to ensure all documents are compliant within the QMS
• Maintain, and update as necessary, the organisational Quality Policy and Objectives, develop and deliver training to ensure the organisation understands and embraces quality procedures
• Lead and implement internal and external auditing practices, provide reporting against standards and statutory obligation compliance
• Ensure preparation and compliance for second and third party audits
• Participate in the liaison with manufacturing sites and product teams to ensure product compliance to pre-determined quality criteria
• Participate in the manufacturer/supplier qualification processes
• Manage Quality Inspection reporting and Release for Supply of all products
• Maintain Corrective Action Preventive Action (CAPA) process and ensure timely follow-up, and implementation of corrective actions
• Initiate, maintain and update all Linear Healthcare Group QMS documentation, including an annual review and amendments as required
• Work cross-functionally and train members of Linear Healthcare Group in the value of Quality and Regulatory compliance
• Provide general administrative support to the Head of Operations.
• Participate in the growth of the Linear Medical business and contribute to develop Linears’ clinical branding image.

Qualifications

To be considered for this exciting role, you will possess:

• Tertiary education (Biomedical engineering/regulatory affairs/health care/science related)
• ISO13845 training will be highly regarded
• Minimum of 2 years recent employment within the healthcare industry
• Ability to work within tight timeframes and across international time zones
• Exceptional verbal and written communication skills
• Intermediate Microsoft Office skills.
• Highly organised with a focus on attention to detail.
• Prior experience working with quality systems/standard operating procedures highly beneficial
• Approach to daily tasks with flexibility, initiative and enthusiasm
• Excellent time management and organisational skills
• Ability to speak Mandarin highly regarded.
• Please be able to provide referees upon request.

To Apply:

Please apply online by clicking apply now within this advertisement. You will need to prepare CV and covering letter which outlines your suitability for the role by addressing the essential criteria.

With respect, no recruitment agencies please.

Applications close: 20 July 2018