Quality Engineer

De Bilt - Netherlands

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 addition you are part of the QA/QC team and may serve as a direct supervisor for interns or 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 ISOCFR 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:

Bachelors 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 ISOCFR 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

Youll 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 companys 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.

Listing on the SIX Swiss Exchange under the symbol KUR
A commercial & research footprint that spans>20 markets
4 teams of internationally renownedclinical and scientific expert advisers
>25orthobiologics-relatedpatents
>400 patients evaluatedin Level I randomized controlled clinical trials
>20well-controlledLevel I-III clinical trials initiated including 6 that are complete
Level I evidence published inSpine

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 complies with GDPR and the California Consumer Privacy Act (CCPA).View our CCPA Noticehere.

Required Experience:

Manager