Quality Assurance Specialist / Document Controller required to work in Killaloe Co. Clare working in a team environment you will be responsible for performing batch history record review while providing support to all areas within the company along with ensuring all documentation within the Quality Management System is introduced, updated and maintained in a controlled manner in compliance with the Document Control Procedure.

Key Responsibilities

· Perform batch record review to release raw materials, components, and finished devices.

· Review and approval of protocols, reports, and documentation updates ensuring compliance with company procedures/policies and regulatory requirements.

· Ensure correct use of statistical QA methods in the production environment.

· Utilize quality tools to track and trend quality performance and identify key opportunities for improvement ensuring all process developments are managed in accordance with the Quality Management System.

· Ensure compliance with all documented Quality management system requirements, as per ISO13485, MDSAP, IVDD, IVDR and FDA.

· As required perform internal audits to ensure compliance of company’s quality management system to the requirements of ISO13485, MDSAP, IVDD, IVDR and FDA.

· Provide training on processes when required to ensure compliance with the quality management system.

· Perform document control notification (DCN) closure in line with procedural requirements.

· Ensure DCN’s are closed in line with timelines required by departments across the company.

· Provide training on the DCN process for new and existing employees as required.

· Provide support on the DCN process for all trained employees.

· Maintain and communicate metrics relating to document control process.

· Conduct internal quality system audits as per annual audit schedule

· Ensure compliance with all documented Quality system requirements, as per FDA QSR’s and ISO 13485:2016

· Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements.

· Other duties as required to support other areas within Manufacturing Quality Assurance.

Skills / experience

· B.Sc. in Science/Engineering/QA/ Documentation Control or related discipline

· Minimum of 3 years practical experience required in a quality function.

· Strong initiative and troubleshooting skills required.

· Strong interpersonal skills and the ability to communicate well both verbally and in writing.

· Excellent attention to detail and ability to prioritize.

For more information or to apply please email your details to [email protected] or call 061 208649 or 087 9077699

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