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Über
All potential candidates should read through the following details of this job with care before making an application.
Company: My client are a Medical device manufacturer with a new hub in Galway.
They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies.
Responsibilities: Act as the Management Representative for the Quality Management System (QMS).
Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
Report on QMS performance and identify opportunities for continuous improvement.
Promote awareness of regulatory and customer requirements across the organization and ensure compliance.
Serve as the primary liaison with customers and certification bodies for external audits.
Provide leadership and direction on all QA-related matters, including quality systems, compliance, and material disposition.
Ensure management review meetings are conducted in accordance with regulatory requirements.
Oversee control of documents and records related to products, manufacturing processes, and the QMS.
Plan, manage, and conduct internal quality audits to ensure compliance with applicable standards and internal procedures.
Handle and monitor CAPA, customer complaints, and feedback to ensure timely resolution and continuous improvement.
Carry out supervisory responsibilities in accordance with company policies and applicable laws, including interviewing, hiring, training, performance management, and employee development.
Plan, assign, and direct work; evaluate performance; recognize achievements; address employee concerns.
Requirements: Education/Experience and Qualifications: 510 years of progressive experience in quality assurance and control within medical device manufacturing or a related industry, with in-depth knowledge of manufacturing processes and quality systems.
Strong management and leadership skills.
Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
Demonstrated proficiency in engineering and quality tools (e.g., FMEA, DOE, SPC, and statistical analysis tools).
Ability to support product development, manufacturing, and product release activities as directed by senior management.
Excellent technical writing and verbal communication skills. xyswxtq
Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on OR Benefits: Bonus, pension healthcare, 4 day week
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Sprachkenntnisse
- English
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