
Manufacturing Quality Assurance Specialist
2 days ago
Our organization is seeking an experienced Manufacturing Quality Assurance specialist to support a comprehensive remediation program following an FDA inspection. This role will focus on validating manufacturing processes, updating quality systems, and ensuring accurate documentation.
The consultant will be based onsite and work closely with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.
The project involves tackling remediation areas in sequence, updating technical files and procedures, and ensuring robust validation of manufacturing processes.
- Collaborate with process owners on the floor to capture and address issues.
- Support process validation (IQ/OQ/PQ) and documentation updates.
- Drive CAPA/NCR closure and implement compliant solutions.
- Develop high-quality technical documents for quality and manufacturing.
- Work collaboratively across functions to ensure regulatory compliance.
Requirements
- Engineering or Quality degree with 5-10 years' experience in medical device industry.
- Background in remediation, process validation, CAPA, NCRs.
- Strong writing and documentation skills.
- Familiarity with 21 CFR Part 820 and ISO 13485.
-
Quality Assurance Specialist
2 days ago
Galway, Galway, Ireland beBeeProblemSolving Full time €60,000 - €80,000Quality Assurance SpecialistThe ideal candidate will be responsible for managing the quality of products and processes within a manufacturing environment.
-
Quality Assurance Specialist
1 day ago
Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000Job Title: Quality Assurance SpecialistIn this role, you will be responsible for ensuring compliance and supporting process validation projects. To succeed in this position, you must have expertise in quality assurance and manufacturing processes.Key Responsibilities:Evaluate and improve manufacturing processes to ensure compliance with regulatory...
-
Quality Assurance Specialist
5 hours ago
Galway, Galway, Ireland beBeeTechnical Full time €72,000 - €96,000Quality Assurance SpecialistThis is a key role in our organization, responsible for managing all Quality related activities on assigned value streams. The successful candidate will be responsible for implementing robust preventative Quality programs, managing product and process issues, and ensuring that products meet design requirements.The ideal candidate...
-
Manufacturing Quality Systems Specialist
5 days ago
Galway, Galway, Ireland beBeeQuality Full time €45,000 - €60,000Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to support and enhance our quality systems ensuring compliance with industry standards. The successful candidate will have a strong ability to work on their own initiative and be looking for long term career growth.This role would be ideal for someone working in an Industrial...
-
Quality Assurance Specialist
3 days ago
Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000Job Title: Quality Assurance SpecialistAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality department, you will be responsible for ensuring that our products meet the highest standards of quality.The ideal candidate will have a strong background in quality...
-
Manufacturing Quality Assurance Expert
2 days ago
Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000Senior Manufacturing Quality AssuranceWe are seeking a highly skilled and experienced quality assurance professional to join our innovative medical device company.This individual will play a critical role in supporting commercial manufacturing of connected health solutions for chronic wound care.Oversee product quality, regulatory compliance, and readiness...
-
Quality Assurance Specialist
3 hours ago
Galway, Galway, Ireland beBeeQuality Full time €55,000 - €70,000Job Summary:We are seeking a Quality Assurance Specialist to lead our quality management efforts. The successful candidate will be responsible for maintaining and improving our company's Quality Management System (QMS) and overseeing quality aspects of internal manufacturing, sub-contract manufacturing partners, and internal projects.Maintain and report on...
-
Galway Quality Assurance Specialist
5 days ago
Galway, Galway, Ireland beBeeQuality Full time €35,000 - €45,000Quality Assurance Specialist RoleWe are currently recruiting for a Quality Assurance Specialist to join our busy food production unit in Galway. You will play a pivotal role in ensuring that our food products consistently meet and exceed quality and safety standards.Prior experience in quality assurance, food manufacturing or a related field is highly...
-
Quality Assurance Specialist
6 days ago
Galway, Galway, Ireland beBeeCompliance Full time €80,000 - €150,000Job Title: Quality Assurance Specialist">This role is responsible for ensuring the highest standards of quality in all engineering projects and day-to-day operations. The Quality Assurance Specialist acts as a key interface between Engineering and Quality functions to ensure that all systems and processes meet EU GMP standards and are inspection ready.">The...
-
Senior Quality Assurance Specialist
5 days ago
Galway, Galway, Ireland beBeeEngineering Full time €80,000 - €120,000Join our search for a talented Quality Assurance Specialist to partner with design, manufacturing, and engineering teams in the introduction of new products and processes.Job DescriptionAs a Senior Design Transfer Quality Engineer at Fisher & Paykel Healthcare, you will provide quality engineering support for New Product Introduction (NPI) and capacity...