Quality Assurance Engineer

Ferrosan Medical Devices; Søborg; On-site; DKK 208,000 - 312,000; Full time

Job summary

Ferrosan Medical Devices in Szczecin, Poland, is seeking a Quality Assurance Engineer to ensure the quality and regulatory compliance of medical devices used worldwide.

You will provide quality oversight of manufacturing processes, support product lifecycle and validation activities, and collaborate with cross-functional teams to maintain ISO 13485 compliance and internal standards, ultimately improving patient safety and product quality.

Qualifications

• University degree in Engineering (Quality Engineering, Biomedical Engineering, Chemistry, or related fields).
• Minimum 3 years of experience in a quality-related role within manufacturing; medical device industry preferred.
• Fluent English (oral and written).
• Solid knowledge of ISO 13485, ISO 14971, ISO 14644 and FMEA methodology.

Responsibilities

• Provide quality oversight for manufacturing processes and independent batch release.
• Define and maintain quality standards, in-process controls and acceptance criteria.
• Lead nonconformity management including RCA, CAPA and quality trend analysis.
• Support risk management activities (ISO 14971, FMEA) and process validation (IQ/OQ/PQ).
• Participate in product lifecycle activities including technology transfer and post-market support.
• Train production personnel and participate in audits (internal, customer, and notified bodies).
• Ensure ongoing compliance with ISO 13485 and internal quality system requirements.

Skills

Quality Assurance

Regulatory Compliance

Root Cause Analysis

CAPA

ISO 13485

ISO 14971

FMEA

Education

University degree in Engineering (Quality Engineering, Biomedical Engineering, Chemistry, or related fields)

Tools

CSV

GAMP 5

Job description

Do you want to make a difference for patients undergoing surgery by securing the compliance and quality of medical devices used by healthcare professionals all around the world?

Here you have the opportunity to get an exciting job, as Quality Assurance Engineer, in an international company, at our site in Szczecin, Poland.

Position Overview

We are looking for a motivated Quality Assurance Engineer to join our team. In this role, you will ensure the quality and regulatory compliance of medical devices used by healthcare professionals worldwide. You will provide quality oversight of manufacturing processes, support product lifecycle and validation activities, and work closely with cross-functional teams to maintain compliance with ISO 13485 and internal quality standards. This is a great opportunity to make a real impact on patient safety and product quality in an international medical device company.

Key Responsibilities

• Provide quality oversight for manufacturing processes and perform independent batch release
• Define and maintain quality standards, in-process controls and acceptance criteria
• Lead nonconformity management, including RCA, CAPA and quality trend analysis
• Support risk management activities (ISO 14971, FMEA) and process validation (IQ/OQ/PQ)
• Participate in product lifecycle activities, including technology transfer and post-market support
• Train production personnel and participate in internal, customer and notified body audits
• Ensure ongoing compliance with ISO 13485 and internal quality system requirements

Required Qualifications

• University degree in the field of Engineering (Quality Engineering, Biomedical Engineering, Chemistry, or related fields)
• Minimum 3 years of experience in a quality-related role within a manufacturing environment, medical device industry experience is strongly preferred
• Fluent English (both oral and written)
• Solid knowledge of ISO 13485, ISO 14971, ISO 14644 standards and FMEA methodology
• Hands-on experience with Root Cause Analysis (RCA) techniques, CAPA and common quality tools

Additional Experience

• Process validation (IQ/OQ/PQ), sterilization, microbiology and biocompatibility knowledge
• Experience with Computer System Validation (CSV, GAMP 5), quality systems and IT/OT systems in manufacturing environments
• Supplier Quality Management and cooperation with suppliers

Personal Competencies

• Strong team player with excellent communication skills
• Analytical, structured and detail-oriented
• Ability to work independently in a regulated environment
• Well-organized with effective prioritization skills

Location

Szczecin, Poland.

We offer an exciting workplace where you can have real influence

We offer an exciting and challenging job and a workplace with strong values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes, and we take our values to work every day - we care about each other, our environment, and our customers, and we win for patients with innovative high-quality products.You will meet a Danish-rooted company growing in number of international colleagues and a way of working where hybrid, digital, learning, and innovation are keywords. And we take pride in having fun

Some of the facts and a little piece of history

Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global medtech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.

We are committed to an inclusive hiring process and equal opportunities for all candidates

At Ferrosan Medical Devices, we believe that making a real difference in healthcare starts with our people. That’s why we aim to build a workplace where everyone feels welcome, respected, and valued - no matter their background, experience, or perspective. Diversity fosters innovation, makes us stronger, helps us grow, and allows us to better support patients and partners around the world.