Senior Quality Engineer — Medical Device (12‑Month FTC)

Collins McNicholas Recruitment & HR Services Group; Athlone; On-site; EUR 70,000 - 90,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is recruiting a Senior Manufacturing Quality Engineer on a 12-month FTC for a well-known medical device client in Athlone. The role provides Quality support to processes, materials and products, ensuring CGMP compliance and alignment with ISO/FDA regulatory requirements.

This on-site position requires collaboration with Manufacturing Engineering, risk assessments, FMEA, CAPA investigations and audits to maintain quality metrics and drive

Qualifications

• 4 years experience working in regulated environments, specifically medical device, FDA or ISO 13485-registered work environments preferred.
• Flexible and available to support business needs as required
• Minimum 3 days work on-site – rotating with other engineers
• Engineering or Science Degree
• Experience in a quality engineer or quality specialist role
• Strong computer skills (MS Excel, PowerPoint, Word etc.)
• Familiarity with statistical tools such as Pareto charts and trend charts.
• Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
• Experience with problem solving techniques
• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

Responsibilities

• Represent Quality function in Site Management meetings as required
• Will act as a delegate for site Manufacturing Quality Lead
• Liaise with Manufacturing Engineering on risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for both new and existing products.
• Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
• Provide guidance on change controls for validation impact.
• Use knowledge of statistics to assist with validation developments and process improvements
• Work with Manufacturing Engineering to develop strategy and sampling plans, for completion of validation for new and existing product lines.
• Lead the analysis and resolution of problems that may reduce the efficient running of production lines.
• Lead and guide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
• Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
• Perform and lead Internal Audits.
• Facilitate and lead external regulatory body audits, i.e., ISO and FDA
• Support the development, analysis and improvement of site Quality Metrics.
• Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
• Will comply with all relevant training required and adhere to relevant associated documentation.
• Follow strict adherence to the requirements of CGMP.
• Lead the enhancement of compliance initiatives for areas of responsibility.

Skills

Quality engineering

Regulatory compliance

Statistical analysis

FMEA & RCA

Auditing

CGMP knowledge

Education

Engineering or Science Degree

Tools

MS Excel

PowerPoint

Word

Job description

Collins McNicholas Recruitment & HR Services Group is recruiting a Senior Manufacturing Quality Engineer on a 12-month FTC for a well-known medical device client in Athlone. The role provides Quality support to processes, materials and products, ensuring CGMP compliance and alignment with ISO/FDA regulatory requirements.

This on-site position requires collaboration with Manufacturing Engineering, risk assessments, FMEA, CAPA investigations and audits to maintain quality metrics and drive