Senior Quality Systems Specialist

Sigmar Recruitment; Galway; On-site; EUR 75,000 - 110,000; Full time

Job summary

Sigmar Recruitment is seeking a Senior Quality Systems Specialist to lead and oversee quality programs across a global medical technology organization. The role is a 12-month contract with potential extension and focuses on compliance with internal and regulatory standards.

You will drive quality policies, manage global quality agreements, mentor team members, and deliver cross-functional process improvements in a regulated environment with an emphasis on collaboration and continuous improvement.

Qualifications

• 4+ years’ QA/regulatory experience in a regulated/medical technology environment
• Ability to interpret regulatory requirements and develop quality systems
• Strong collaboration and communication across functions

Responsibilities

• Oversee development, implementation, and review of quality programs to ensure compliance with internal and regulatory standards
• Act as SME on quality policies and regulatory requirements; guide operating entities and drive process improvements
• Lead Quality Agreement negotiations and contribute to developing global, uniform standards across functions
• Independently manage projects from design to execution and mentor junior teammates

Skills

Project management

Regulatory interpretation

Communication

Quality assurance

Education

University degree required

Advanced degree preferred

Job description

Senior Quality Systems Specialist

As a Senior Quality Systems Specialist, you will play a key role in leading and overseeing quality systems and programs across the organization. This is a 12-month contract with a poosibility of extending.

About Your New Employer

• Join a leading global medical technology innovator with a strong reputation for excellence and collaborative culture.
• Be part of challenging, high-impact projects that support major healthcare solutions worldwide.
• Experience a mission-driven workplace with a focus on continuous improvement and best-practice sharing.

About Your New Job

• As a Senior Quality Systems Specialist, you will oversee the development, implementation, and regular review of quality programs, ensuring full compliance with internal and regulatory standards.
• Act as the subject matter expert on quality policies and regulatory requirements. Provide guidance to operating entities, drive process analysis, and enforce quality assurance best practices.
• Lead Quality Agreement negotiations and contribute to developing global, uniform standards, fostering knowledge sharing and alignment across functions.
• Independently manage projects from initial design to full execution, providing mentorship and support to less-experienced team members.

What Skills You Need

• University Degree required (Advanced degree preferred).
• Minimum 4 years’ relevant experience (or 2+ years with advanced degree) in quality assurance, ideally in a regulated or medical technology environment.
• In-depth expertise in interpreting regulatory requirements and developing quality systems.
• Demonstrated project management skills and experience driving process improvements.
• Strong communicator, skilled at collaborating and building consensus with both internal and external partners.

What's on Offer

• Competitive salary and bonus package
• Excellent career development opportunities in a global organization
• Opportunity to work with a talented team on projects with real-world healthcare impact