Senior Quality Engineer Job Description
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This job is a part of an inclusive and diverse organization. The role requires implementing and maintaining the quality management system, ensuring adherence to established guidelines and standards.
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The ideal candidate will assist the Quality Manager in creating and issuing company quality documentation, including standard operating procedures. They will also conduct internal audits, create audit findings reports, and determine proper corrective and preventive actions.
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A member of the New Product Introduction team, the successful candidate will be responsible for generating quality documentation and working with Production to solve in-house quality concerns. Regular monitoring of production areas to ensure product manufacturing and sterilization as per relevant quality documentation is also required.
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Liaising with sterilisation sub-contractor for routine sterilisation activities and associated product testing is necessary. Strong knowledge of ISO 13485, FDA regulations Part 820, and Medical Device Directive (93/42/EEC) is preferred. Working experience of EO and gamma sterilization processes with knowledge of associated standards (ISO 11135 & ISO 11137) is advantageous.
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Required Skills and Qualifications:
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* Degree in Quality/Science or Engineering
* Experience in a Quality role within a similar manufacturing organization
* Knowledge of ISO 13485, FDA regulations Part 820, and Medical Device Directive (93/42/EEC)
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Benefits:
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* Equal opportunities employer
* Employee Resource Groups: EmpoWer, Mental Health, Unite
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Others:
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We are looking for individuals who can bring different perspectives and experiences to our team. If you have a passion for quality and customer satisfaction, we encourage you to apply. A competitive compensation package is offered for this position.