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Details
NPD Quality Manager
| Reference: | TG- QM - Galway | Location: |
Galway Galway City |
| Qualification: | Degree | Experience: | 7-9 Years |
| Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Lead Quality Engineer, QA Engineer, QA Manager, QA RA Engineer, QA Specialist, QA Supervisor, Quality Control Supervisor, Quality Manager
Job title: Quality Manager
Location: Galway
Benefits: Top salary, Bonus, pension, healthcare
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:
- Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
- 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:
- 5–10 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.
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 087 0612325 OR [email protected]
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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