Senior Quality Engineer – Medical Devices
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, you will:
- 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.
What's Next
Apply now or contact rkeyes@sigmar.ie for more information. If you’d like to learn more before applying or are considering similar roles, please get in touch! We have several contract, temporary, and permanent positions available.
