Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery‑free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by an external wearable. Through our commitment to innovation and clinical evidence, we have shown best‑in‑class outcomes for reducing the burden of OSA. For more information, visit nyxoah.com.
Job Title: Manufacturing Quality Engineer
Department: Quality
Reports To: Sr. Manager, Quality Assurance
Position: Full Time
Position Summary
The Quality Engineer will provide hands‑on Quality Engineering support to manufacturing operations and oversee contract manufacturing partners located in Europe, US and Israel. This role is responsible for ensuring compliance with FDA QMSR, ISO 13485, and internal Quality System requirements, while driving continuous improvement, risk reduction, and right‑first‑time execution across internal and external manufacturing operations. This position requires close collaboration with Operations, Engineering, Supply Chain, and external manufacturing partners in a regulated medical device environment.
Key Responsibilities
* Provide day‑to‑day Quality Engineering support to manufacturing operations, including Nonconformance management and disposition, Root cause investigations and CAPA development, Effectiveness verification and trending.
* Support process validations (IQ/OQ/PQ) and ongoing process monitoring.
* Review and approve manufacturing documentation, including: DMRs, work instructions, routings, and manufacturing change controls
* Support product release activities and ensure compliance with defined acceptance criteria.
* Participate in GEMBA walks, shop‑floor quality reviews, and continuous improvement initiatives.
* Lead quality aspects of manufacturing transfer projects, ensuring seamless transition of products from one facility to another while maintaining compliance with regulatory requirements and quality standards.
* Plan, coordinate, and execute process validation activities, including process performance qualification (PPQ) and process validation protocols, to ensure manufacturing processes meet Nyxoah's specifications and regulatory requirements.
* Conduct risk assessments to identify potential quality and regulatory risks associated with manufacturing transfers and process qualifications and develop strategies to mitigate these risks.
* Manage documentation related to transfer projects and process qualifications, ensuring accuracy, completeness, and compliance with regulatory requirements.
* Collaborate with contract manufacturers to establish and maintain quality agreements, conduct supplier audits, and address any quality issues related to transfer projects and process qualifications.
* Drive continuous improvement initiatives to enhance manufacturing processes, reduce defects, and increase efficiency during transfer projects and process qualifications.
* Work closely with cross‑functional teams, including engineering, operations, regulatory affairs, and quality assurance, to ensure successful execution of transfer projects and process qualifications.
* Ensure compliance with applicable regulatory requirements, standards, and guidelines throughout transfer projects and process qualification activities, including FDA regulations and ISO standards.
* Provide guidance, training, and support to contract manufacturer personnel involved in transfer projects and process qualification activities, ensuring understanding and compliance with quality requirements and procedures.
Qualifications
* Bachelor’s degree in Engineering. A master’s degree is a plus.
* At least 4 years of experience in quality engineering roles, preferably within the medical device industry. Experience with Class II or Class III medical devices is a plus.
* Thorough understanding of medical device regulations and standards, including FDA QSR (21 CFR Part 820), ISO 13485, and other relevant regulations in the regions where the company operates is highly valued.
* Proficiency in implementing and maintaining quality management systems (QMS) in accordance with regulatory requirements, including document control, CAPA (Corrective and Preventive Action), and risk management.
* Experience in process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), process capability studies, and statistical process control (SPC).
* Strong analytical and problem‑solving skills to identify root causes of quality issues and implement effective corrective and preventive actions (CAPA).
* Familiarity with quality tools and methodologies such as FMEA (Failure Mode and Effects Analysis), DMAIC (Define, Measure, Analyze, Improve, Control), and statistical analysis.
* Ability to work effectively with cross‑functional teams, including engineering, manufacturing, regulatory affairs, and supply chain, to ensure compliance and drive continuous improvement.
* Excellent written and verbal communication skills to effectively communicate quality‑related information to internal teams, external partners, and regulatory agencies.
* Professional certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred.
What We Offer
* The opportunity to work on a life‑changing technology that treats Sleep Apnea.
* A dynamic, international, and entrepreneurial environment where you can truly make an impact.
* Significant career growth opportunities as the company scales its global operations.
* A competitive salary and benefits package.
We thank all applicants for their interest in our organization, however; only those selected for an interview will be contacted. This position is based in Belgium and is subject to Belgian employment law. The successful candidate must be legally authorized to work in Belgium at the time of hire.
Nyxoah is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability or any other protected status in accordance with applicable laws. All employment decisions are based on qualifications, merit, and business needs.
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