Quality Manager Medical Technology

Job Type : Full Time

Number of Applicants

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Job Description - Quality Manager Medical Technology

Develop and lead the monitoring and continuous improvement of the QMS compliant with relevant global jurisdictional medical device requirements.
Audit, qualification and review of key service providers, manufacturing partners and supply chain. Serve as Management Representative in any audit by a regulatory authority / Notified Body and lead all audit communications with audit personnel from a regulatory agency. Support preparation of documents for technical file submission.
Lead quality at Lightpoint. Collaborate with and provide functional leadership and support to team members in quality function.
Collaborate closely with the cross functionally within Lightpoint and establish relationships with Telix as appropriate to executing responsibilities. Ensure an efficient and effective quality management process.
Ensure release and handling of products (soft- and/or hardware) for use in clinical trials and commercially is compliant with documented procedures and product is within specification.

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