About the role

Quality Assurance Specialist supporting manufacturing and engineering teams at Kardium. Ensuring quality excellence and maintaining the Quality Management System in a hybrid work environment.

Responsibilities

Support Manufacturing & Engineering Teams
Review production and engineering documentation, from Device Master Records and DHRs to verification/validation plans, test protocols, and change requests
Execute QA release of incoming materials, in-process goods, and finished products
Contribute to root cause investigations, process validations, and equipment qualifications
Review software tool implementation and validation documentation
Participate in internal audits and manage QMS project activities
Maintain document control in line with Kardium policies and procedures

Bachelor's degree in a technical discipline (e.g., engineering, biotech, pharmaceutical sciences)
3+ years of QA experience in biotech or medical device manufacturing
Strong working knowledge of ISO 13485, FDA QSR, and EU MDD requirements
Familiarity with document control systems (electronic systems a plus)

Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period.
Work-day flexibility – additionally, we provide 3 personal days per year.
Support – for you (and your dependents) overall well-being.
Career progression and learning support.
Professional membership support.
Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.