Senior Quality Engineer

Your role

As a Senior Quality Engineer, you will play a central role in safeguarding product quality across the full lifecycle - from development and validation through manufacturing, release, and post-market activities. You’ll act as the key bridge between Quality, Manufacturing & Operations, R&D, and Global Product Management, ensuring that our products consistently meet rigorous regulatory, safety, and performance standards.

This is a fully on-site position based in Dołuje, near Szczecin.

Your tasks

• Lead and manage core elements of the Quality Management System, including CAPAs, complaints, change controls, nonconformances, audits, and calibration/maintenance.

• Oversee verification and validation activities for new products and product improvements, ensuring full compliance with international standards.

• Coordinate product testing, release processes, and quality control methodologies within the Quality Centre.

• Manage global return, complaint, and incident analysis, driving timely completion, trend evaluation, and reporting requirements.

• Lead Post-Market Surveillance and Risk Management activities.

• Provide clear, data-backed communication on product quality to internal stakeholders and customers.

• Implement quality improvements across production processes and distribution centers.

• Maintain and develop the electronic document management system.

• Manage and mentor the Quality team, ensuring alignment with operational and compliance goals.

• Drive new quality initiatives and continuous improvement efforts.

• Ensure full compliance with ISO 13485, ISO 9001, and applicable regulatory requirements.

Who you are

• Relevant technical degree.

• 5-10 years of experience in quality assurance.

• Experience in product and process validation.

• Understanding of Manufacturing and Mechanical principles.

• Proficiency in MS Office, especially Excel for data analysis.

• Fluency in Polish & English.

• Readiness to travel to our different production sites.

Experience in a regulated medical device environment and working knowledge ISO 13485 would be a huge advantage.

What we can offer

Our Icelandic roots inspire a culture of strong team spirit, and genuine collegiality. 

• Purpose & Impact: Your work will directly shape our product strategy and improve lives globally 

• An international team culture – Collaborate with colleagues across borders in a diverse and inclusive environment. 

• Private medical care – Comprehensive health coverage to support your well-being. 

• Growth & Development: Collaborate with industry leaders and grow your career in a dynamic, international environment 

• One-shift work model: A stable daytime schedule that helps you balance your responsibilities, wellbeing, and productivity.

Join us in our mission to improve Peoples mobility!

Össur is a leading global provider of prosthetics and bracing and supports solutions.

Embla Medical is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best available individual in every job.

Embla Medical's equal opportunity policy prohibits all discrimination (based on race, color, creed, sex, religion, marital status, age, national origin or ancestry, physical disability, mental disability, military service, pregnancy, child birth or related medical condition, actual or perceived sexual orientation, or any other consideration made unlawful by local laws around the world).

Embla Medical is committed to complying with all applicable laws providing equal employment opportunities. This commitment applies to all individuals involved in the operations of Embla Medical and prohibits discrimination by any emplo​yee of Embla Medical, including supervisors and co-workers.

Important Warning: Beware of fraudulent recruiters impersonating our company. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. We will never ask you for any form of payment during the recruitment process. Please make sure you refer to our official website.