Quality Engineer

About the Role
As a Quality Engineer, you play a vital role in ensuring the quality and regulatory compliance of our medical devices throughout the entire product lifecycle. You will collaborate closely with internal and external stakeholders, including colleagues, consultants, and customers. In addition, you are part of the QA/QC team and may serve as a direct supervisor for interns or trainees. In your absence, responsibilities will be taken over by the Quality Engineering Manager or a qualified colleague.

Your responsibilities include implementing and maintaining the quality management system, managing non-conformances, and driving continuous improvement. We are looking for a professional with in-depth knowledge of medical device regulations and a strong commitment to product safety and effectiveness.

Key Responsibilities

Product Quality & Technical Work:

• Support product development, design verification, and validation activities;


• Develop and implement quality control plans for manufacturing processes;


• Analyze quality data and identify trends for process improvement.

Validation:

• Support process and equipment validations (IQ/OQ/PQ);


• Prepare and manage validation documentation.

QA/QC & Regulatory:

• Manage quality documentation and ensure compliance with applicable regulations;


• Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR Part 820, and other relevant standards;


• Conduct internal and external audits;


• Support regulatory inspections and submissions;


• Handle non-conformances and CAPA processes through thorough root cause analysis;


• Conduct risk assessments and develop risk management plans in line with ISO 14971.

Safety & Organizational Responsibilities:

• Comply with safety protocols and guidelines, including those related to chemical, infectious, and radioactive materials;


• Participate in the evaluation and implementation of new procedures, materials, and equipment;


• Train and guide colleagues and interns;


• Use resources (time, materials, equipment) efficiently and responsibly.

Who Are We Looking For?

Required Education and Experience:

• Bachelor’s degree in engineering, life sciences, or a comparable field;


• At least 3 years of experience as a Quality Engineer in the medical device industry;


• Extensive knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and relevant regulations;


• Experience with audits, CAPA, risk management, and validation processes;


• Strong problem-solving skills and excellent communication skills in both Dutch and English;


• Able to work independently as well as effectively in a professional team;


• Proficient in quality management software and Microsoft Office (Word, Excel, PowerPoint, SharePoint, OneDrive).

Qualifications:

• Experience with Statistical Process Control (SPC);


• Familiarity with design control processes;


• Experience with HR systems is a plus.

What We Offer:

• A challenging and responsible position within an innovative and growing company;


• A close-knit team of professionals passionate about quality and healthcare;


• Opportunities for personal development and training;


• Maximum salary of and attractive secondary benefits.

Why join us?

You'll be part of an ambitious, multidisciplinary team dedicated to improving patient outcomes through smart material science. We value initiative, creativity, and a pragmatic approach. We offer a supportive environment where scientific excellence goes hand-in-hand with product impact.

About Us:

Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.

Our credentials:

With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOsTM, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.

• Listing on the SIX Swiss Exchange under the symbol KUR


• A commercial & research footprint that spans >20 markets


• 4 teams of internationally renowned clinical and scientific expert advisers


• >25 orthobiologics-related patents


• >400 patients evaluated in Level I, randomized controlled clinical trials


• >20 well-controlled Level I-III clinical trials initiated, including 6 that are complete


• Level I evidence published in Spine

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.