Senior Quality Assurance Specialist (CAPA)

Make a Meaningful Impact Join Us as a Senior Quality Assurance Specialist(CAPA)

Are you passionate about quality collaboration and making a difference in healthcare Were looking for a Senior Quality Assurance Specialist (CAPA) to join our team and help us ensure the highest standards in patient safety and product excellence.

Why This Role Matters

In this role youll be at the heart of our quality operationsleading CAPA processes partnering with cross-functional teams and contributing to a culture of continuous improvement. Youll work closely with R&D Engineering Operations and Regulatory Affairs to resolve quality challenges and shape our compliance strategy.

What Youll Do

Lead CAPA Excellence

• Guide and mentor colleagues through CAPA methodology and execution.

• Manage CAPA lifecycle from initiation to closure ensuring timely and effective outcomes.

• Review and approve CAPAs supporting thorough investigations and root cause analysis.

• Oversee implementation and verification of corrective and preventive actions.

Strengthen Our Quality System

• Support the development and maintenance of quality procedures aligned with global standards.

• Monitor compliance across departments and promote best practices.

• Function as contact point for compliance topics to empower teams with quality knowledge.

Support Microbiology & Sterilization

• Collaborate with subject matter experts on microbiological controls and EtO sterilization.

• Contribute to environmental monitoring sterility assurance and validation activities.

• Help ensure compliance with ISO 11135 and related regulatory frameworks.

What You Bring

• A Bachelors or Masters degree in Science Engineering or a related technical field.

• At least 5 years of experience in the medical device industry ideally in a quality-focused role.

• Strong skills in non-conformance handling root cause analysis and CAPA implementation.

• Solid understanding of international medical device regulations:

• ISO 13485:2016

• 21 CFR Part 820

• EU MDD/MDR

• ISO 14971 (Risk Management)

• Familiarity with ISO 11135:2018 and/or IEC 60601-1 is a plus.

• Excellent communication skills in English.

• Strong organizational and time management abilities.

• A proactive ethical mindset and the ability to work both independently and collaboratively.

• Confidence using technical software and digital tools.