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If you are looking for a company with a global reach that can offer you excellent career opportunities and personal development along with a local collaborative team then click below.
This is a brilliant opportunity for an individual who wants to continue their growth and development within the Operational QA area and who is looking for a chance to fully own aspects of their role while working in a supportive and nurturing environment.
A bit more about the role:
* Supporting in the supervision of Quality Technicians and QC Inspectors.
* Drive and implement process improvements to ensure predictable processes across all product lines.
* Provide effective and responsive QA support to Operations.
* Ensure all failure modes in process have been identified and addressed (e.g., use of DOE studies, FMEA's).
* Drive and implement plant-wide quality system improvements.
* Ensure regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g., FDA and TUV).
* Provide functional expertise to other support functions on quality-related issues (e.g., regulatory requirements, statistical techniques, sampling principles).
* Approval of change requests for product, process, and quality system changes.
* Customer complaints: analysis of returns, approval of analysis reports, and analysis of complaint trends.
* Validation: define process and product validation requirements, preparation and approval of Master Validation Plans, protocols, and reports approval.
* Compilation of required regulatory documentation (e.g., technical files, design dossiers, product transfer files, essential requirements).
* MRB: review of MRB trends and identification of appropriate corrective actions when required.
* Perform internal quality audits.
* Support the implementation of Lean Manufacturing across the site.
* Transfer and implement product and processes from development or from another manufacturing facility.
Background, Education & Experience:
* 2-5 years' experience in Manufacturing or Quality in a highly regulated environment. Previous medical device experience is preferred but open to other regulated industries depending on background.
* Level 8 qualification in Engineering or related technical/Quality discipline.
* Demonstrated ability to work with cross-functional organizations in a dynamic manufacturing environment to solve problems.
* Ability to rapidly learn and use new applications.
* Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
* Experience in problem-solving and process improvement methodologies.
* Process validation, risk management, CAPA experience.
If you would like a confidential discussion about this role or other opportunities then get in touch with Kellie today on 021 2300 300 or on the below email.
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