Quality Assurance Specialist - Process
Job no: 493297
Work type: Permanent - Full time
Location: Sydney
Categories: Regulatory Affairs & Compliance
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…
We are currently looking for an individual with a robust technical background, impeccable attention to detail, and a proactive problem-solving approach. Our ideal candidate should prioritize teamwork and demonstrate a dedication to continuous improvement. If you thrive in a Quality team environment and are ready to make a significant impact, we encourage you to apply.
About you...
At Device Technologies, we succeed through our commitment to four key values:
Delivering Innovation – We encourage and reward fresh ideas and are committed to supporting our people to make change.
Seeking Collaboration – We support each other in our combined mission to help others achieve their goals.
Taking Ownership – We believe in equipping our people to take responsibility and accountability in their roles and trust them to get the job done.
Practising Good Business – Our success is built on a mix of intuition and experience and we foster an environment where all voices are heard and nobody is afraid to make mistakes.
Our ideal candidate for this role aligns with these values.
Qualifications, Skills and Experience
Essential
- Understanding of Device Technologies policies and procedures including any vaccination and background checks in line with your role and responsibilities.
- 3+ years’ experience in medical device or related industry
- Must possess significant level of knowledge of the ISO standards (ISO 9001, ISO 13485, ISO 19011)
- Strong experience with NCR and CAPA management including root cause analysis
- Strong background in internal or supplier auditing
- Auditing qualifications - Internal auditor or Lead Auditor certification
- Experience with QMS within medical device industry
- Great communication skills
- Ability to work well independently and as part of a team
Desirable
- Tertiary qualification in related field or equivalent work experience
- Familiarity with supplier management process
- Experience with developing and delivering training modules
What we offer:
- Excellent work environment
- An intellectual challenge
- Ability to learn and grow
- Sense of community
- Flexible work options
- A competitive salary, Rest, Energize & Connect (REC) days and Birthday leave!
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.
Advertised: AUS Eastern Daylight Time
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