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* Australian owned global company, Head office located in Ringwood, Victoria
* Established Quality team
* Full time, permanent role
Trajan's vision 'Science that benefits people' is a commitment to enrich the wellbeing of a growing number of communities by having an impact on human health. Our manufacturing footprint extends from Ringwood in Victoria, Australia; to Penang, Malaysia; Austin, Texas;, and Raleigh, North Carolina. Our focus is on developing and commercializing technologies that enable analytical systems to be more selective, sensitive and specific for biological, environmental or food related measurements.
Be part of a dynamic and friendly team environment and leading global organisation by joining us. This is an excellent opportunity to progress your career in the field of Quality.
The successful candidate will be responsible for the following:
* Ensure that the QMS:
* conforms to ISO 9001 requirements, and other standards as they become applicable.
* effectively promotes a customer centric model that achieves the right balance between "commercial" and "process" established in consultation with, Business Unit Managers and other stakeholders.
* encompasses current regulatory, ESG and supply chain requirements as advised by the appropriate department manager.
* enables the timely execution and delivery of projects, including prototyping, and the introduction of new products that meet customer needs.
* is scalable, such that it can support the integration of new businesses and/or capabilities, including the establishment of new certifications, in-line with the company's growth plans.
* Provide management and oversight of the QMS functions, including the underlying Quality processes, to support the business meeting customer needs efficiently and effectively. This includes:
* The deployment and day-to-day management of Quality resources to work directly with the business functions on identifying and resolving inefficient processes.
* Management and oversight of CAPA, IQA, Document Control, and other QMS processes.
* Working closely with the QC team on communicating customer complaints and monthly reporting on QMS metrics
* Oversee implementation of training, including core Quality skills for professional and manufacturing staff.
* Working and collaborating with global site QA leads for an efficient and effective execution of QMS functions across all sites.
* Providing QMS advice to relevant business functions with respect to product and process
* The regular review of product, process and systems as part of continual improvement
* Support the transfer of developed products (excluding Medical Devices) from R&D to production.
* Lead the organization in preparing for second party and third-party audits and risk-based internal audits
* Performs Supplier QMS audits as required
The successful candidate will ideally possess:
* Strong knowledge of Quality Systems– ISO 9001 and/or13485, FDA CFR 21 Part 820 and ISO 14971 and the application within a manufacturing environment
* A business acumen with the ability to achieve balance between internal process and customer needs
* Effective analysis and interpretation of customer data (including complaints) and the effective communication within the organisation.
* Ability to achieve outcomes through the actions of others and communicate those outcomes
* Strong communication and listening skills and the ability to foster knowledge sharing demonstrated by an ability to generate effective reports that meet the protocols of the QMS, and the report's objectives, for both internal external stakeholders
* A proven record in managing internal audit program
* An understanding of Risk Management principles and application in an ISO 9001 environment
* Strong knowledge of Microsoft Suite of packages
Trajan is an Equal Opportunity Employer encouraging flexibility and fostering an environment that celebrates diversity.
You must be a permanent resident or have an unrestricted Working Visa to apply for this position.
To apply online please click the 'Apply' button below.
For more information on Trajan, visit our website:
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing, Manufacturing, and Biotechnology Research
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