Senior Quality Engineer

Sigmar Recruitment; Galway; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Competitive salary package

Defined contribution pension plan

Comprehensive health and life 보험

Job summary

Sigmar Recruitment in Galway is seeking a Senior Quality Engineer for a global MedTech leader. The role focuses on quality engineering, design transfer, and medical device compliance, with in-depth work on Design Control and risk management.

You will mentor engineers, lead validation activities (TMV, MVP, IQ/OQ/PQ), review ECNs, support audits, and travel internationally. Fluency in English and French is required.

Qualifications

• Bachelor’s Degree in Engineering or related field (or equivalent experience).
• 8+ years of engineering experience, ideally within medical devices or a regulated industry.
• Fluency in English and French.
• Deep knowledge of 21 CFR 820, ISO 13485, ISO 14791 and related regulatory standards.
• Strong expertise in Design/Process Validation (TMV, MVP, IQ/OQ/PQ).

Responsibilities

• Provide quality engineering support for products and processes, focusing on design transfer activities and ensuring compliance with medical device regulations.
• Lead design team activities as a subject matter expert in Design Control throughout the development process.
• Coordinate risk analysis and management activities, lead risk meetings, and drive continuous improvement and risk mitigation initiatives.
• Review, approve, and generate Engineering Change Notifications (ECNs), ensuring verification, validation, and production monitoring for product lines.
• Conduct technical studies and solve complex problems using innovative approaches and the latest scientific techniques.
• Mentor, train, and evaluate engineers, technicians, and quality auditors on compliance and best practices.
• Review nonconformance records, determine root causes, and drive corrective and preventive actions to maintain quality standards.
• Support internal and supplier audit activities, ensuring the effectiveness of corrective/preventive actions.

Skills

Fluency in English

Fluency in French

Design/Process Validation

Design Control

Risk management

Statistical methodologies

Six Sigma/Lean tools

Root cause investigation

QualityAuditing

Education

Bachelor’s Degree in Engineering or related field

Tools

Minitab/JMP

Oracle

Spreadsheets

Word processing

Databases

Job description

Senior Quality Engineer – Medical Devices

* Fluency in English and French required for this role

About Your New Employer

• Join a leading, award-winning global MedTech company with over 30 years of consistent growth and innovation in medical device manufacturing.
• Be part of a high-performing team in Galway with a collaborative environment, diverse workforce (30+ nationalities), and excellent track record of internal promotions—almost 60% of roles filled internally.
• Benefit from a dynamic, people-focused workplace recognized with the \"Medtech Company of the Year\" award and committed to employee development and wellbeing.

About Your New Job

As the Senior Quality Engineer,youwill:

• Provide quality engineering support for products and processes, focusing on design transfer activities and ensuring compliance with medical device regulations.
• Lead design team activities as a subject matter expert in Design Control throughout the entire development process (Design Inputs, Process Validation, TMV, DMR creation).
• Coordinate risk analysis and management activities, lead risk meetings, and facilitate continuous improvement and risk mitigation initiatives.
• Review, approve, and generate Engineering Change Notifications (ECNs), ensuring robust verification, validation, and production monitoring for your product lines.
• Conduct technical studies and solve complex problems using innovative approaches and the latest scientific techniques.
• Mentor, train, and evaluate engineers, technicians, and quality auditors on compliance and best practices.
• Review nonconformance records, determine root causes, and drive corrective and preventive actions to maintain quality standards.
• Support internal and supplier audit activities, ensuring the effectiveness of corrective/preventative actions.

What Skills You Need

• Bachelor’s Degree in Engineering or related field (or equivalent experience).
• Minimum 8 years of engineering experience, ideally within medical devices or a regulated industry.
• Previous experience as a Manufacturing Engineer is highly advantageous.
• Fluency in English and French.
• Deep knowledge of 21 CFR 820, ISO 13485, ISO 14791, and related regulatory standards.
• Strong expertise in Design/Process Validation (TMV, MVP, IQ/OQ/PQ).
• Solid knowledge of statistical methodologies, root cause investigation, Six Sigma/lean tools, and quality control practices.
• Proficiency in common software (e.g., spreadsheets, word processing, databases).
• (Preferred) Advanced skills with Minitab/JMP, Oracle, and ASQ CQE certification.
• Some travel may be required internationally.

What's on Offer

• Competitive salary package
• Defined contribution pension plan
• Comprehensive health and life insurance
• Health & wellbeing initiatives, subsidized canteen & barista service, free parking
• Excellent internal training, education assistance, and career progression opportunities
• Recognition schemes with an active sports and social club
• This role is fully onsite during probation with the opportunity to move to hybrid post probation.