Quality Assurance Manager

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, commits committed to tasks, and accurate way of working.