Quality Assurance Specialist

Quality Assurance Specialist role at Device Technologies. 12-month parental leave cover. Located in Sydney, Australia.

• Administer Quality Management System for the business and relevant entities
• Manage quality documentation to meet the organization's needs in compliance with ISO 9001 requirements
• Perform internal audits as a Lead Auditor supporting the internal audit program
• Perform supplier audits as a Lead Auditor
• Monitor and support timely execution of internal and supplier audits
• Prepare for audits by researching materials, standards, policies and procedures to formulate a plan of action
• Recruit, train and ensure competency of a team of internal auditors
• Ensure that non-conformities are recorded and the resultant actions are effective
• Identify and execute opportunities for continuous improvement
• Promote awareness and understanding of the Quality Management System
• Design training resources and provide training for quality related processes
• Assist RAQA management with other functions as required and support other elements of a QA system e.g., non-conformances, process improvements etc.
• Must possess significant level of knowledge regarding global Medical Device Regulations (ISO 9001, ISO 13485, ISO 19011)

At Device Technologies, we succeed through our commitment to five key values:

• Delivering Innovation - We constantly seek new ideas, technologies, and approaches to meet evolving customer needs and market demands. Through our innovation we continually adapt and transform for our people, our customers and our future success.
• Seeking Collaboration - By embracing collaboration we tap into diverse perspectives, skills, and resources to drive innovation, solve complex problems, and achieve common goals.
• Taking Ownership - We embrace accountability and initiative. It fosters trust, collaboration, and empowers our people to drive success through proactive responsibility.
• Practising Good Business - We strive to embody integrity, responsibility, and sustainability. It involves ethical conduct, transparency, and a commitment to social and environmental stewardship.
• Championing the Customer - By placing customers at the heart of decision-making and operations, we enhance experiences, foster loyalty, and collectively strive to improve patient outcomes.

Our ideal candidate aligns with these values.

• 2+ years' experience in medical device internal or supplier auditing
• Experience with QMS within medical device industry
• Significant knowledge of ISO standards (ISO 9001, ISO 13485, ISO 19011)
• Auditing qualifications - Internal auditor or Lead Auditor certification
• Strong background in auditing and Quality Management Systems best practice
• Ability to work well independently and as part of a team
• Expertise in MS Office Suite
• Bachelor's in related field, or equivalent work experience, preferred
• Familiarity with supplier management process
• Experience with developing and delivering training modules

Interested?

To apply for this opportunity, please click on the apply button to be redirected to our candidate application portal.

At Device Technologies we are motivated by the opportunity our equipment provides to change people's lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of our business.

Our promise is all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different.

Please note: Device Technologies will undertake pre-employment checks via our accredited background check provider. An offer is subject to identity check, reference checks, right to work checks and police integrity. Some roles may require certifications and/or vaccination status confirmation during the interview process.

• Quality Assurance
• Industries: Medical Equipment Manufacturing