Quality Assurance Officer
3 months ago
**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 opportunity for a **Quality Assurance Officer **to join the RAQA team to effectively administrate the Quality Management System policies and processes for Device Technologies.
**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.
**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
- Work on Document Control system reviewing, updating and releasing the QMS documents
- Liaise with staff, senior management and external auditors on all QMS issues;
- Work with departmental managers to ensure ongoing effectiveness of procedures and work instructions;
- Develop and deliver training and induction materials relevant to QMS;
- Ensure the effective promotion of awareness of customer requirements and process improvement throughout the organization;
- Coordinate and participate in Quality reviews, supplier audits and other external audits.
- Schedule and conduct internal audits;
- Assist RAQA management with other functions as required and support other elements of a QA system e.g., non-conformances, process improvements etc.
**Qualifications, Skills, and Experience**
**Essential**
- Experience in Quality Assurance within a medical device environment preferred
- Ability to prioritize work, manage multiple priorities and deliver tasks on time with a high level of accuracy
- Strong attention to detail and organizational skills
- Good written and verbal communication skills
- Ability to work autonomously as well as a team player who is willing to work in and support the team when necessary Positive outlook
- Understanding of Device Technologies policies and procedures including any vaccination and background checks in line with your role and responsibilities.
**Desirable**
- Possess a Bachelor’s degree/tertiary Education in a relevant science field.
- Preferably 2-3years’ experience in the healthcare industry preferably Medical device or pharmaceutical
- Practical knowledge and experience with ISO 9001 or 13485 Quality Systems standards
- Formal auditing qualifications or willing to qualify
- Familiarity with supplier management, risk assessment and project implementations
- SAP experience preferred
**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?**
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.
- 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._
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