Senior Quality Assurance Specialist (Design & Development)

Senior Quality Assurance Specialist – Design Development & Change Control

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Industry: Medical Devices

Location: Utrecht region, Netherlands

Working: Hybrid – approximately 60% onsite post-onboarding

Set-up: Direct contract with the client (perm) | Initial 12-month contract with long-term opportunity

About the Opportunity

I'm working with an innovative international medical device company that's developing technologies to improve spinal surgery. As they continue to grow, they're looking for an experienced Senior Quality Assurance Specialist to join their team in the Netherlands.

This is a great opportunity for someone who enjoys working closely with R&D , supporting new product development, and making sure quality is embedded throughout the design process.

What you'll be doing

You'll be the Quality partner for Design & Development and Change Control, working closely with R&D as well as Regulatory Affairs, Operations, and Supply Chain. This is a hands-on role where you'll help bring structure to quality processes, support business growth, and influence how teams approach quality.

Key responsibilities include:

• Supporting Design & Development from a Quality perspective.
• Leading Change Control activities and improving associated processes.
• Working cross-functionally to ensure quality and compliance throughout the product lifecycle.
• Driving continuous improvement across quality processes.
• Advising and supporting stakeholders on quality best practices.
• Supporting audits and regulatory compliance.

What they're looking for

• 5+ years' experience in a Senior QA role.
• Strong experience supporting Design & Development or New Product Development.
• Experience with Change Control and quality process management.
• Comfortable working independently and influencing stakeholders.
• A confident communicator who can explain the "why" behind quality decisions.
• Medical device experience preferred; biotech experience will also be considered.
• Engineering background preferred.
• Knowledge of ISO 13485 and/or FDA Quality System Regulations is a plus.

What's on Offer

• Join an innovative international medical device organisation developing life-changing technologies.
• Take ownership of quality activities supporting new product development and organisational growth.
• Work in a collaborative, cross-functional environment with significant exposure to R&D and business stakeholders.
• Opportunity to make a tangible impact on quality systems and processes.
• Competitive salary (range: 70-90K including holiday allowance) and benefits package.
• Flexible working options with 32 or 40-hour contracts possible.
• Hybrid working model with approximately 60% onsite presence.
• Based in the Utrecht region.

Please note: this role isn't suitable for candidates whose experience is solely within pharmaceutical manufacturing QA.

If you're interested in learning more, or know someone who could be a great fit, feel free to get in touch. Interviews kick off mid-August.