Overview
Senior Quality Engineer Jobs in Galway Metropolitan Area at CREGG
Title: Senior Quality Engineer
Company: CREGG
Location: Galway Metropolitan Area
Senior Quality Engineer – Summary of Responsibilities and Requirements
CREGG Recruitment are hiring for a Senior Quality Engineer to join a multi national start up Medical Device company in Galway. This is a great opportunity for an engineer to join the team as a Senior Quality Engineer, gaining broad experience across the company.
The Successful candidate will gain Capital equipment and Process Validation experience within the role.
Salary 90,000 – 120,000k per year
12 month contract with view to going permanent after one year
Catheter Experience advantageous
Key Responsibilities:
Ensure compliance with company policies and applicable national/international regulations.
Drive quality system improvements and maintain compliance (e.g. CAPA, audits, training).
Apply structured problem-solving techniques to resolve quality issues.
Support process development for catheter and capital equipment builds.
Oversee quality control activities including lot release and incoming inspections.
Provide expert guidance in quality assurance, systems, and regulatory compliance.
Manage risk (FMEA, risk files) and documentation associated with process changes.
Develop and implement control/inspection/testing plans to meet design and regulatory standards.
Maintain inspection/test records and manage non-conformance documentation.
Analyze and report on quality metrics, driving continuous improvement.
Develop verification/validation protocols and reports.
Review and approve product/process changes in accordance with regulatory and internal procedures.
Essential Skills & Experience:
Degree in Quality Engineering, Life Sciences, or a related discipline.
3–5 years’ experience in medical device QA, ideally in an FDA/MDR-regulated setting.
Familiarity with capital equipment (advantageous).
Certifications in Quality and Lead Auditing (preferred).
Solid knowledge of FDA 21 CFR Part 820, ISO 13485, and applicable standards.
Proficiency in quality tools: FMEA, SPC, RCA, CAPA, investigations.
Proven experience with QA processes in medical device manufacturing.
Strong organizational, interpersonal, and communication skills.
Ability to manage multiple priorities in a fast-paced environment.
Fluent English, with strong technical writing skills.
Demonstrated initiative, problem-solving skills, and sound decision-making
