Quality Assurance Specialist

About us…

Since 1992, Device Technologies has been dedicated to improving patients' lives through leading edge technology and services,
supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world.Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and ongoing support provided by our people. With HQ in Sydney, the company continues to grow, representing over 200 trusted brands, and employing over 1000 highly skilled staff located across Australia, New Zealand and Asia.

Geared towards optimal performance, our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We focus on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce.

The opportunity…

An exciting opportunity awaits an experienced Quality professional to join the ANZ Quality team in a 12-month parental leave cover role.

Key Responsibilities:

• Administer Quality Management System for the business and relevant entities
• Manage quality documentation to meet 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)

About you...

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 embracingcollaborationwe 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 for this role aligns with these values.

Experience required:

Essential

• 2+ years' experience in medical device internal or supplier auditing required
• Experience with QMS within medical device industry
• Must possess significant level of knowledge of the 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
• Great communication skills
• Ability to work well independently and as part of a team
• Expertise in MS Office Suite

Desirable

• Bachelors 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 for the successful candidate to ensure that Device Technologies is meeting legislative obligations and the information a candidate provides is accurate. For all roles, an offer of employment will be subject to the following pre-employment checks: identity check, reference checks, right to work in location (checks for visa holders), police integrity. By proceeding and applying for the role, you acknowledge our hiring process and agree to undertake the required pre-employment checks if successful.

It is also a mandatory requirement for certain roles within our organisation, where the successful applicant may be required to present certifications and/or vaccinations status as per role requirements. Evidence of certificates or vaccination status will be requested during the interview process by management to qualify fit for role and prior to any offer.