Quality Specialist

3 days ago

Macquarie Park, Australia BD Full time

**Job Description Summary**: Opportunity for a Quality Specialist to join our established Quality team in Macquarie Park, Sydney.

We are **the makers of possible**

BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

**Job Description Summary (For Illustrative Purposes Only)**

We are searching for a Quality Specialist to join our team Maintain and implement QA systems and policies to ensure GMP and ISO requirements, including SOPs, non-conformance management and audit programs.

**Responsibilities**
- Manage Document Control and work with stakeholders to ensure timely implementation of new and revised procedures.
- Responsible for the Change Request process including SAP Document Control
- Responsible for Greater Asia and Corporate procedure review and incorporation of requirements to ANZ QMS as necessary.
- Manage the Learning Management System (MasterControl and C2C) to ensure all associate training records are appropriately maintained and accessible.
- Work across functions including (but not limited to) Supply Chain and engineering to ensure effective transfer of workflow for daily activities as well as CI and integration related activities.
- Develop relationships between departments to assist with the above activities.
- Participate and support Internal, External and Supplier Audit requirements.
- Responsible for Supplier Management Process.
- Ensure timely close out of Audits and associated nonconformances and CAPAs
- Represent ANZ on the GA SMAT network.
- Document quality issues and performance measures for Management Review
- Participate in the use of quality management techniques in the improvement of all company processes across BD.
- Undertake project work as requested by the Quality Director, ANZ.
- Cross train in, and perform, other quality assurance support activities as required, such as Complaints Processing.
- Adhere to the requirements of the Quality Management System as maintained by BD ANZ.

**Preferred Requirements: (For Illustrative Purposes Only)**
- Medical, Medtech or pharmaceutical experience preferable
- Experience in Quality management systems - ISO 9001 minimum and/or ISO 13485 (Advantageous)
- Post market experience in recalls
- Proficient in Excel
- Complaint intake systems - Salesforce, Workday, SAP, JDE, BuySmart, Concur, TrackWise and ADP
- Cross-functional and regional stakeholder engagement - Supply chain, Customer Service, Finance and Sales etc
- Operational SOPs, learning management systems and tender support
- Proactive and uses initiative
- Agile learner

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

**Primary Work Location**: AUS Sydney - North Ryde

**Additional Locations**: AUS Brisbane, AUS Melbourne

**Work Shift**:

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