A fast-paced, rapidly growing Medical Device business in Ireland is seeking a motivated and experienced Quality Specialist to support the development and maintenance of their Quality Management System (QMS), ensuring compliance with ISO 13485, ISO 9001, FDA QSR, and relevant regulatory requirements. This role covers medical device design, development, manufacturing, and distribution.
Key Responsibilities:
1. Foster a quality culture, adhering to company manufacturing standards, policies, and procedures.
2. Support the implementation and maintenance of the QMS, including change controls, CAPAs, non-conformance documentation, documentation control, employee training, and design & development controls.
3. Investigate and resolve quality issues using root cause analysis and recommend improvements.
4. Drive continuous improvement initiatives and perform QA verification of production activities.
5. Review and update Quality System documentation as necessary.
6. Participate in internal and external audits (customers, Notified Bodies, Competent Authorities).
7. Lead qualification and validation activities (equipment, processes, test methods, software).
8. Review and approve batch records and device history records.
Qualifications and Requirements:
1. Experience working with Medical Devices, ISO 13485.
2. Hands-on experience with NCRs, CAPAs, audits, and change control processes.
3. Strong, reliable Quality Specialist with the ability to meet deadlines and drive initiatives forward.
4. Proficient in process, cleaning, test method, and equipment validation.
5. Auditing experience (internal and supplier) is essential.
6. Comfortable in a hands-on, dynamic environment with the ability to manage multiple projects.
7. Strong systems and administrative skills, with a focus on quality management.
8. A team player skilled in problem-solving, change management, and risk management.
9. Experience with New Product Introduction (NPI) and sustaining/maintenance activities.
If you’re an experienced professional who thrives in a fast-paced, hands-on environment, we want you to join our team!
Please apply to this advert via LinkedIn.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Manufacturing, and Engineering
Industries
Engineering Services, Manufacturing, and Medical Equipment Manufacturing
#J-18808-Ljbffr