Quality Assurance Specialist

Job Role: Quality Assurance 

About the Role:
We are seeking an experienced Quality Assurance Specialist to oversee and continuously improve our Quality Management System (QMS) within a pharmaceutical/medical device environment. You will manage change control, support production and R&D teams, lead audits, oversee complaint and CAPA processes, and ensure compliance with global regulatory and quality standards. You will act as a key link between cross-functional teams, senior leadership, and regulatory bodies.

Key Responsibilities:

-Manage change control processes and maintain local procedures and specifications.

-Ensure compliance with GMP, ISO 13485, ISO 14971, MDR/MDD, and QSR CFR 820.

-Lead internal (CQA) and external audits (DEKRA/FDA) and address observations.

-Investigate, trend, and report customer complaints; review and approve complaint reports.

-Manage CAPAs, deviations, and non-conformities across production and quality functions.

-Support production teams with process changes, escalations, and continuous improvement initiatives.

-Release batches after confirming all procedural and compliance requirements are met.

-Provide R&D support through risk analyses, validation plans/reports, DHF audits, and design reviews.

-Analyze data on deviations, complaints, and rejects to identify structural improvement opportunities.

-Roll out corporate and franchise procedures and maintain QMS integrity.

-Prepare and report quality metrics and contribute to Site Management Reviews.

Requirements:

-BSc or equivalent degree in Life Sciences, Engineering, or a related field.

-4–6 years of relevant experience in pharmaceutical or medical device QA.

-Knowledge of GMP, ISO 13485, ISO 14971, MDD/MDR, and QSR CFR 820.

-Experience with validation, risk management, and quality systems.

-Proficiency in MS Office and understanding of quality improvement methodologies.

Practical Information:

Location: Groningen, The Netherlands

Start Date: ASAP

Work Model: Hybrid 

Interested or know someone who might be?
Send your CV or inquiries to e.cabral@panda-int.com