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Senior quality assurance specialist

Ballina
beBeeRegulatory
Quality assurance specialist
Posted: 25 January
Offer description

Quality and Regulatory Affairs Manager


As a senior professional, you will be responsible for overseeing the entire quality and regulatory affairs function to ensure compliance with international standards, regulatory requirements, and health safety legislation.


* Develop an integrated management system (IMS) that aligns with industry best practices.
* E nsure compliance with ISO 9001, ISO 13485, and ISO 27001 certifications by integrating QMS processes across sites. Streamline operations to maintain consistency.
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The successful candidate will have excellent leadership skills to manage corrective and preventive actions (CAPA) teams effectively. They must also oversee document control and change control processes while ensuring timely closure of findings from internal audits coordinated with external audits.

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