Senior Quality Engineer (Design Assurance)

Design Assurance Quality Engineer

About Your New Employer

• Global Leader in MedTech: One of the largest global medical technology companies, dedicated to advancing the world of health.
• Innovative Culture: Work alongside inspirational leaders and colleagues in a growth-centered and inclusive environment.
• Impactful Work: Contribute to transformative solutions that make the world a better place.

About Your New Job

• Quality Representation: Act as the Quality representative on project core teams, overseeing design controls, risk management, and change control processes.
• Compliance Management: Ensure adherence to global regulatory requirements, including IEC 60601 and IEC 62304.
• Documentation and Verification: Manage Design History File (DHF) documentation, review and approve verification and validation plans, and challenge statistical rationales.
• Risk and Issue Management: Lead risk management activities, assist in failure investigations, and manage software issue tracking.
• Quality Advocacy: Promote a strong quality culture across projects and support broader Quality Management System (QMS) activities.

What Skills You Need

• Educational Background: Relevant degree or equivalent experience (engineering degree preferred) or a minimum of 5 years of quality engineering experience.
• Regulatory Knowledge: Experience with ISO 13485, QSR, ISO 14971, and statistical techniques.
• Design Assurance Expertise: Proficiency in design controls, standards compliance, and risk management.
• Communication Skills: Strong written and verbal communication skills.
• Organizational Skills: Strong organizational abilities.
• Advantageous Experience: Familiarity with MDR, IEC 62304, and IEC 62366.

What’s on Offer

• Competitive Salary: Attractive compensation package.
• Professional Growth: Opportunities for learning and development in a dynamic work environment.
• Work-Life Balance: Flexible work arrangements with a minimum of 4 days of in-office presence per week.

What’s Next

Apply now by clicking the “Apply Now" button or call me on +353 21 4847136 (Email afitzpatrick@sigmar.ie). If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Permanent, FTC, and Contract jobs available.