QA / RA Officer – Work on next level medical devices!

Location:

Apeldoorn – Gelderland, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

131795542

Posted On:

14 April 2025

QA/RA Specialist – Medical Devices (Apeldoorn Region)
Make an impact in healthcare innovation

Are you passionate about improving healthcare and enhancing patient wellbeing through cutting-edge medical technology? This is your chance to join a dynamic team in the Deventer region that specializes in therapeutic interventional oncology products. In this role, you’ll contribute to the development and compliance of life-enhancing technologies, while working in a supportive environment driven by respect, ownership, and continuous improvement.

About the Role
As QA/RA Specialist, you will play a vital role in ensuring that medical products meet global regulatory requirements and maintain the highest quality standards. You will support the QA/RA Manager in strategic initiatives, help maintain technical documentation, and manage cross-functional projects that drive both compliance and innovation.

Key Responsibilities

Maintain and update technical documentation (e.g., Technical Dossiers, Design History Files) for global regulatory submissions (EU, US, Canada).
*

Support QA/RA strategy aligned with global marketing goals, identifying regulatory pathways and documentation needs.
*

Monitor changes in regulations and standards, conduct gap analyses, and lead compliance improvement initiatives.
*

Ensure compliance in product development and change management processes.
*

Contribute to continuous quality improvements and operational efficiency.
*

Serve as (or grow into) Lead Auditor for the Quality Management System (QMS).
*

Lead and coordinate cross-functional teams to support product registrations and QMS enhancements.
*

Oversee CAPA processes and related quality initiatives to drive proactive problem resolution.

What You Bring

Experience in QA/RA within the medical device industry
*

Knowledge of international regulatory frameworks (e.g., MDR, FDA, ISO 13485)
*

Strong project coordination and communication skills
*

Detail-oriented with a proactive, solution-driven mindset
*

Audit experience and knowledge of QMS platforms is a plus

Why Join Us
You’ll be part of a collaborative and purpose-driven team based in the Deventer region, working on technologies that truly make a difference in patients’ lives. You’ll have the opportunity to grow professionally while contributing to meaningful healthcare innovation.

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.