- Compile and maintain regulatory documentation in accordance with applicable regulations.
- Manage efforts associated with the preparation of regulatory documents or submissions.
- Interpret regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- New Product Introduction.
- Move to One Global QMS
- Non-conformance / complaint investigation and the implementation of robust corrective action.
- Participate in an audit readiness program to ensure readiness for all audits, both announced and unannounced audits.
- Assist in the analysis of quality systems with the intention of designing, promoting, and implementing systems and processes for continuous improvement, compliance to new markets and customer satisfaction.
- Ensure the reporting of assigned quality activities is carried out accurately and in a timely fashion in keeping with the requirements of the management information system and S.O.P in place.
- Ensure the Plant hygiene and standard of GMP is maintained.
- Ensure all reports are prepared accurately and issued in a timely fashion.
- Ensure that excellent standards of quality are maintained throughout the business processes and monitor those standards on an ongoing basis.
- Carry out projects and duties as assigned by your manager in an efficient, timely and cost-effective manner.
- Participation in global projects as assigned by your manager, when required.
- Assist in fulfilling regulatory requirements, as required:
- Compiling or updating of regulatory and/or technical documentation.
- Updating of regulatory databases or systems.
- Ensure that satisfactory standards of quality and regulatory are maintained and ensure the Quality system at all times meets ISO 13485 and any other standards which may apply.
- Manufacturing Practices( Includes gowning requirements in all production areas and hand hygiene)
- Documentation Practices
- Facility Security
- Comply with all standard operating procedures in place relevant to your work activities ensuring not to perform any tasks you have not received training in.
- Comply with the requirements of the Quality Management System and relevant standards.
- Educated to degree or equivalent level in a Quality or Scientific discipline.
- Must have experience in Quality Assurance within a medical device company or pharmaceutical field.
- Experience with regulatory affairs and CAPA an advantage.
- Knowledge of Regulatory Requirements (MDD/MDR or FDA) an advantage
- Must have a flexible approach to work and be capable of handling multiple priorities in a fast-paced environment.
- Strong attention to detail with a high degree of accuracy and excellent organisational and communication skills.
- Ability to work with and empathize with colleagues and customers from varied backgrounds and cultures.
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Quality Engineer - Kells, Ireland - Run My Recruitment
Description
This permanent position will be responsible for ensuring requirements are met with regard to the Quality Management System and associated regulations.
Essential Job Functions:
Participate in the following quality system activities as required:
Supplemental Job Functions:
Comply with the following standard operating procedures:
Education/Experience
Key Competencies