Quality Assurance Manager
ARTIDIS
Summary
The Quality Assurance Manager is responsible for documenting and reviewing quality-related processes as required according to EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes. This function ensures that the product developed meets the organization's quality standards before it is launched into the market. The Quality Assurance Manager reports to the Head of Quality Management.
Job description
Job Purpose
The Quality Assurance Manager is responsible for documenting and reviewing quality-related processes as required according to EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes. This function ensures that the product developed meets the organization's quality standards before it is launched into the market. The Quality Assurance Manager reports to the Head of Quality Management.
Duties and Responsibilities
- Creates, reviews and trains quality related processes and procedures.
- Collaborate with other departments to support quality related processes and procedures.
- Identifies the training requirements.
- Maintains oversight of the quality management system including but not limited to records, changes, corrective actions, preventive actions, process verifications, process validations, test methods validation, and technology transfer.
- Creates documentation of internal audits and quality assurance activities.
- Supports Gauge Management.
- Supports Risk Management.
- Supports Training Management.
- Ensures that the QMS is thorough, accurate, and compliant to support inspections and audits.
- Provides support during regulatory inspections and audits and is responsible for overseeing and performing auditing efforts to ensure compliance with regulatory guidelines.
- Identifies quality system improvements when gaps are identified through audits and departmental reviews.
- Proactively investigates and identifies improved quality practices.
- Performs other related duties as assigned.
Qualifications
- Digital Native, with experience in using AI for QMS purposes.
- Good Hands-on practice of maintaining Quality Management Systems.
- Strong knowledge in the EN ISO 13485, FDA QMSR, MDSAP, and EU IVDR.
- At least 3 years of working experience in an EN ISO 13485 quality-controlled environment.
- Hands-on experience in incoming inspection and release of goods, with familiarity in quality review and documentation practices.
- Strong analytical skills with the ability to interpret quality data and identify trends for continuous improvement.
- Comfortable working in a dynamic, fast-paced start-up or scale-up environment.
- Strong communication skills for cross-functional collaboration and audit readiness.
- Proficiency with quality systems and document control platforms; working knowledge of ERP/MRP systems is a plus.
- Excellent written and spoken English.
- Positive can-do, will-do attitude: values others and works well independently and in a team environment.
- Reliable, structured, committed to tasks, and accurate way of working.
Requirements
- Digital native with experience using AI for QMS purposes
- Hands-on practice maintaining Quality Management Systems
- Strong knowledge of EN ISO 13485, FDA QMSR, MDSAP, and EU IVDR
- At least 3 years of working experience in an EN ISO 13485 quality-controlled environment
- Hands-on experience in incoming inspection and release of goods
- Familiarity with quality review and documentation practices
- Strong analytical skills to interpret quality data and identify trends
- Comfortable in a dynamic, fast-paced start-up or scale-up environment
- Strong communication skills for cross-functional collaboration and audit readiness
- Proficiency with quality systems and document control platforms
- Working knowledge of ERP/MRP systems is a plus
- Excellent written and spoken English
- Positive can-do attitude; works well independently and in a team
- Reliable, structured, committed, and accurate way of working
Benefits
- Competitive salary
- Performance bonus
Company overview
ARTIDIS AG is a clinical-stage medical technology company headquartered in Basel, Switzerland, with additional operations in Houston, Texas. Founded in 2018, the company has developed a pioneering nanotechnology platform that combines atomic force microscopy with artificial intelligence for rapid tissue analysis and therapy optimization. ARTIDIS specializes in measuring the biomechanical properties of cancer cells and tumor microenvironments to predict metastatic potential and treatment response. Their proprietary technology enables same-day analysis of biopsy samples, providing clinicians with actionable insights for personalized cancer treatment decisions. The company's platform integrates nanomechanical measurements with molecular, clinical, and imaging data through their ARTIDISNET analytics system. With a focus on improving outcomes for cancer patients, ARTIDIS is advancing predictive biomarkers for chemotherapy sequencing, targeted therapies, and immunotherapy optimization. The company has raised significant funding, including a $27 million Series A round in 2023, and collaborates with leading cancer research institutions worldwide.