Senior Quality Assurance Specialist

About Motek Medical

Motek Medical uses advanced AR/VR technology to set the standard for human movement research and treatment. Our immersive systems help clinicians and researchers assess, rehabilitate, and advance the science of how people move — improving recovery and quality of life for patients around the world.

Quality is at the heart of everything we do, from the design of our products to the way we work together as a team. We're looking for a results-driven Senior QA Specialist who doesn't just maintain a quality system, but takes ownership of it — someone who has led ISO certification and built quality management systems from the ground up, and who brings a hands-on, can-do attitude to keeping our QMS strong, compliant, and audit-ready.

Job Overview

We are seeking a highly skilled, results-driven Senior QA Specialist to take ownership of quality and compliance across the development and manufacturing of our medical devices. This is a role for someone who leads rather than supports: you'll drive our quality management system forward, own regulatory compliance throughout the product lifecycle, and be the person the wider team looks to on quality — all while contributing to a collaborative team that genuinely enjoys working together.

If you have successfully led an organization through ISO certification and established or matured a QMS to meet it, this role is built for you.

Key ResponsibilitiesQuality Systems Management

• Own the development, implementation, and continuous improvement of the quality management system in line with relevant regulations and standards (e.g., ISO 13485:2016, FDA 21 CFR Part 820, Regulation (EU) 2017/745).
• Lead the organization toward and through ISO certification and re-certification, driving readiness across teams and serving as a key contact during external audits.
• Plan and conduct internal audits, translate findings into measurable improvements, and hold the organization accountable to closure.
• Define, track, and act on KPIs that measure and drive QMS performance.
• Partner with manufacturing and supply chain to drive the control of nonconforming material, acceptance activities, part qualification, process validation, and related activities to effective outcomes.

CAPA

• Own the Corrective and Preventive Action (CAPA) system, driving timely, root-cause-based, and effective problem-solving to closure.

Document Control

• Own the documentation supporting quality processes, procedures, and test records, ensuring it is accurate, current, and accessible to relevant stakeholders.

Training

• Own the training matrix and ensure quality training is completed, documented, and demonstrably effective.

Collaboration

• Work closely with Engineering, Manufacturing, and Regulatory Affairs to embed quality throughout the product lifecycle.
• Act as a trusted advisor on quality issues, and lead continuous improvement initiatives with a positive, solution-oriented mindset.

Qualifications

• Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).
• Minimum 5 years of hands-on experience building, maintaining, and improving a Quality Management System (QMS) in a regulated environment.
• Demonstrated success leading ISO certification and establishing (or substantially maturing) a QMS
• Demonstrated, in-depth knowledge of ISO 13485:2016 and proven experience applying it to a working QMS.
• Working knowledge of additional medical device regulations and standards (e.g., FDA 21 CFR Part 820, Regulation (EU) 2017/745).
• Proven quality assurance experience within the medical device or pharmaceutical industry.
• Strong analytical, problem-solving, and root-cause skills, with a bias toward measurable results.
• Excellent communication and collaboration abilities, with a can-do attitude, ownership mindset, and strong team spirit.

Preferred Qualifications

• ISO 13485 internal/lead auditor certification (or ASQ CQA / CBA, or similar).
• Experience with electronic quality management systems (eQMS).
• Familiarity with risk management (ISO 14971) and with statistical methods and tools.

What We Offer

• A meaningful role in a company whose products genuinely improve people's lives.
• A collaborative, supportive team that values initiative and fresh ideas.
• Real ownership of the quality function and room to shape how we work.
• Opportunities to grow your expertise in quality and regulatory affairs.
• Competitive salary and benefits - flexible hours, additional holiday bridge days, pension, travel allowances.

How to Apply

Please send your CV and a short cover letter to Het emailadres op click.jobroute.io bekijken with the subject line "Senior Quality Specialist Application." We review applications on a rolling basis and look forward to hearing from you.

Motek Medical is an equal opportunity employer. We welcome applicants from all backgrounds and are committed to building a diverse and inclusive team.