Quality Engineer

Location: Athlone
Contract Type: 12-Month Fixed Term
Working Hours: Monday to Friday, 9:00am to 5:00pm (39 hours per week)
Pay Rate: €32.63 per hour
Start Date: ASAP
Number of Positions: 1

Purpose of the Role:

The QUA Engineer will be responsible for initiating and executing defined quality activities aimed at improving or developing new systems and processes. This role plays a vital part in ensuring product quality, regulatory compliance, and continuous improvement within a regulated environment.

Key Responsibilities:

• Initiate and complete technical and cost-saving activities for process improvements including risk documentation, test methods, process/software validation, and procedural updates.
• Initiate, review, and approve change controls.
• Perform statistical analysis and interpret data using appropriate statistical tools and methods.
• Develop and implement effective sampling strategies.
• Write and review CAPAs, non-conformance reports (NC/NCMRs), and supplier corrective action requests (SCARs).
• Ensure ongoing compliance in Product Manufacturing, Packaging, and Labelling.
• Conduct internal and supplier audits to verify compliance.
• Support and participate in external audits by regulatory bodies (e.g., ISO, FDA).
• Collect, compile, and analyse Quality Metrics and other performance data.
• Maintain compliance with training requirements and associated documentation.
• Follow Environmental, Health and Safety (EHS) and CGMP policies and procedures.
• Contribute to the continuous improvement of compliance initiatives across the business.

Required Experience:

• Minimum of 3 years\’ experience in a regulated environment, preferably within the medical device sector or an FDA/ISO 13485 certified environment.

Required Skills:

• Strong attention to detail.
• Strong computer proficiency, especially in MS Excel, PowerPoint, and Word.
• Familiarity with statistical tools (e.g., Pareto charts, trend analysis).
• Experience with risk management tools such as FMEAs and root cause analysis.
• Strong problem-solving skills.
• Clear and effective communication skills – both verbal and written.
• Ability to work in a fast-paced, team-oriented environment.
• Experience in change control implementation within a medical device setting.
• Demonstrated adherence to CGMP and compliance standards.

Education:

• A degree-level qualification in Quality, Science, or Engineering is required.

Additional Information:

• Flexibility to travel and support business needs if required.
• This is a team-based role and the ability to collaborate effectively is essential.