Product Complaint & Post Market Quality Associate

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…

This is an exciting new regional role based in Malaysia. The Product Complaint & Post Market Quality Associate will primarily be responsible for managing product complaints and providing support for Quality Management Systems (QMS). This role will play a key role in facilitating communication and collaboration with other territories across Asia while conducting internal audits to ensure adherence to quality standards and regulatory requirements.

Key Responsibilities:

Product Complaints:

• Administration of Product Complaint system including:
  • Maintain an accurate and up to date record of all complaints;
  • Maintain spreadsheets;
  • Liaise with overseas suppliers, customers, sales team and internal staff to obtain effective and timely outcomes;
  • Investigate complaints, ensuring accuracy and completeness of information prior to recording of complaint;
  • Notify complaints to relevant manufacturer;
  • Notify patient-related incidents to RA and/or authorities as required;
  • Ensure effective follow up on completed complaints, including provision of replacement product and/or credit, follow up letter to customer, etc.
  • Regular reporting to RA management as required;
  • Collate product complaints information for annual TGA reporting.
• Presentation of Product Complaints process to new employees including company inductions.
• Display the core values and behavioural code of Device Technologies;

Post Market:

• Understand and communicate the AE and/or FSCA to the country RAs in the region.
• Ensure the AE and FSCA are executed in a timely manner and the documents are in place and closed.

Quality Assurance:

• Monitor compliance with Quality System procedures and work instructions;
• Ensure the promotion of awareness of customer requirements throughout the organization;
• Liaise with staff, senior management and external auditors on all Quality System issues;
• Schedule and conduct internal audits;
• Manage quality documentation;
• Work with departmental managers to ensure ongoing effectiveness of procedures and work instructions;
• Internal Quality System auditor;
• Member of the Quality Management Review Committee (QMRC).

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.

Experience required:

• Experience managing post-market quality and Quality Management Systems.
• Experience with Internal Audit
• Effective communication skills, demonstrating clarity and conciseness.
• Attention to detail.
• Capability to work autonomously and collaboratively within a team.

Desirable

• Tertiary qualification in relevant field (generally Science, Biomedical Engineering, etc)
• Experience using SharePoint, SAP and Adobe Professional.

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 Sterling RISQ 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.