Job PurposeThe 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 written and spoken.
- Positive can-do, will-do attitude: values others and works well independently and in a team environment.
- Reliable, structured, commitscommitted to tasks, and accurate way of working.
Working Conditions The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.
