Key Skills

Job Description

Introduction OrbusNeich is a global medical device company specializing in the development, manufacturing, and commercialization of innovative cardiovascular solutions. With a strong focus on interventional cardiology, the company is dedicated to advancing patient care through cutting-edge technologies, high-quality products, and continuous innovation. Operating across international markets, OrbusNeich combines scientific expertise with a commitment to excellence, delivering medical solutions that improve outcomes for patients worldwide. About the Role At OrbusNeich, we are looking for a Quality Assurance Engineer (QMS & EMS) to support and continuously improve our Quality Management System (QMS) and Environmental Management System (EMS). In this role, you will help ensure that our products, processes, and quality activities comply with applicable regulatory requirements, industry standards, customer requirements, and internal procedures. Depending on your experience level, you will take on increasing responsibility in quality processes, environmental management, audits, CAPAs, and continuous improvement initiatives. You will report directly to the Site Quality Manager and play a key role in maintaining our ISO 13485 and ISO 14001 compliant systems. Key Responsibilities Medior Level Coordinate day-to-day ISO 14001 EMS activities. Maintain EMS documentation, records, registers, and action plans. Monitor environmental performance indicators and compliance obligations. Coordinate EMS communication, awareness initiatives, and audit preparations. Support the maintenance and effectiveness of the QMS and EMS. Perform process monitoring and periodic quality checks. Oversee controlled processes such as cleanroom monitoring and contaminated product handling where applicable. Initiate and manage low-risk CAPAs, NCMRs, and internal audit findings. Senior Level In addition to Medior responsibilities: Act as process owner for assigned QMS and/or EMS processes. Lead continuous improvement initiatives and controlled changes within QMS and EMS. Develop and improve quality and environmental strategies. Analyze trends related to CAPAs, NCMRs, audit findings, quality metrics, and environmental performance. Lead CAPAs, NCMRs, audit findings, and EMS improvement actions. Prepare and present quality and environmental reports to senior management. Lead QMS and EMS meetings and improvement projects. Collaborate closely with Engineering, Production, and Development teams. Act as deputy PRRC/QA Manager and/or QC Supervisor when formally appointed. Who We're Looking For We are open to candidates at Mid-Level, and Senior levels. We value a proactive mindset, a commitment to quality, and the willingness to continuously learn and improve. Medior HBO degree or equivalent work experience. Minimum 2 years of experience as a QA Engineer. Experience with ISO 13485 and ISO 14001. Experience with internal audits. Familiarity with statistical analysis. Experience tracking EMS objectives, actions, and compliance obligations. Senior HBO degree or equivalent work experience. Minimum 5 years of experience as a QA Engineer. Strong knowledge of ISO 13485, ISO 14971, MDR, and ISO 14001. Certified and experienced internal auditor (ISO 19011, ISO 13485 and/or ISO 14001). Familiarity with statistical analysis. Experience leading projects, small teams, and QMS/EMS improvement activities. Preferred Qualifications Additional certifications in: Quality Assurance. Environmental Management. ISO 13485. ISO 14001. FDA regulations. Internal Auditing. Key Competencies Strong critical thinking and problem-solving skills. Analytical mindset with excellent attention to detail. Strong communication and interpersonal skills. Effective time management and prioritization abilities. Ability to work independently and collaboratively. Proactive approach toward quality and environmental improvements. Professional proficiency in English. What We Offer Competitive salary based on experience and level. Annual discretionary bonus. Holiday allowance. Company pension scheme. Travel allowance. 27 vacation days per year, 1 additional vacation day during your birthday month and opportunity to earn 2 additional vacation days through our attendance program. Ongoing training and professional development opportunities. An international, innovative, and growing medical device environment. The opportunity to contribute to products that improve patients' lives worldwide. Why Join OrbusNeich? Join a global medical device company dedicated to improving patient outcomes through innovation and excellence. You'll have the opportunity to make a direct impact on quality, compliance, and sustainability while working alongside passionate professionals in a highly regulated and rewarding industry. Interested? We'd love to hear from you!

Core Responsibilities

Maintain and improve the site's Quality Management System and Environmental Management System, ensuring compliance with applicable regulations, standards, customer requirements, and internal procedures. Coordinate or lead audits, CAPAs, nonconformance actions, environmental initiatives, process monitoring, reporting, and cross-functional improvement projects according to seniority.

Requirements

Candidates need an HBO degree or equivalent experience, with at least two years of QA Engineer experience for the mid-level role or five years for the senior role. Experience with ISO 13485, ISO 14001, internal audits, and statistical analysis is expected; senior candidates should also have strong knowledge of ISO 14971 and MDR, audit certification and experience, and a record of leading improvement activities.

Benefits

• Annual Discretionary Bonus
• Holiday Allowance
• Company Pension Scheme
• Travel Allowance
• 27 Vacation Days
• Additional Birthday-Month Vacation Day
• Opportunity to Earn Two Additional Vacation Days
• Training and Professional Development