Supplier Development and Quality Engineer

Zo maak jij het verschil

As a Supplier Quality Engineer, you will manage material quality issues, working with suppliers to contain problems and conduct root cause analysis using tools like 8D and Fishbone. You’ll develop quality plans, promote a zero-defect culture, and ensure compliance with standards like ISO13485 and ISO9001. Your role includes conducting Supplier First Article Inspections, performing audits, and managing Quality Assurance Agreements. You will drive process improvements, support supplier development initiatives like LEAN and Six Sigma, and ensure quality in the Product Creation Process while maintaining audit-ready compliance documentation.

Wat jij mee brengt

You, as the ideal Supplier Development and Quality Engineer will recognise yourself in the following:

• Bachelor or Master in an engineering discipline or equivalent
• 5 + years experience in engineering, manufacturing and supplier quality/development  in a regulated industry 
• Knowledge of ISO13485, ISO9001, ISO14001, ISO14971, QSR 21, CFR Part 820
• Professional proficiency in English and Swedish, written and spoken    

 

Jouw voordelen

What we offer:

• Contributing to Life-Changing Solutions: Your work directly impacts patient outcomes by developing and improving cutting-edge medical devices used in life-saving therapies.
• Sense of Purpose: Knowing that your efforts are helping to improve patient care and shape the future of minimally invasive therapies will give you a deep sense of fulfilment and pride