Key Responsibilities and Tasks:
General Quality Assurance
– Assume responsibility for establishing, implementing, and monitoring cross-functional quality processes throughout the company’s product life cycle.
– Review, edit, and maintain all existing QMS policies, including those related to training, CAPAs, ECOs, and MRBs.
– Lead efforts to implement, upgrade, and expand the company’s SOPs (Standard Operating Procedures).
– Oversee the company’s training procedures.
– Supervise the daily QA activities of the company.
– Prepare for and manage audits and certification tasks.
– Align QA goals with the company’s long-term strategy and regulatory requirements.

Manufacturing & Operations
– Monitor the transition of designs into the production phase.
– Manage and conduct incoming inspection and approval processes.
– Handle equipment maintenance for the company.
– Implement procedures for inventory management.
– Take responsibility for product release procedures.
– Manage relationships with contractors and vendors.
– Define procedures for quality control and in-process control (QC/IPC).
– Compile Device Master Records (DMR) and Device History Records (DHR).

Design Control, Verification, and Validation
– Compile Design History Files (DHF) and Technical Files.
– Participate in defining and executing verification and validation (V&V) testing protocols, along with their associated rationales.
– Lead validation activities related to product release procedures, such as sterilization, packaging, and transportation.
– Actively collaborate with Engineering and Research and Development (Eng/RD) teams, providing support for Design and Development (D&D) activities.
– Maintain the risk management file and engage in cross-functional activities related to risk management.

Requirements:
– Possess a Bachelor of Science (B.Sc.) degree or higher in a technical discipline, preferably in a life science-related field.
– Have at least 3 years of experience in implementing or managing quality systems in medical devices, with a preference for Class III devices.
– Demonstrate experience working under ISO 13485 standards.
– Display critical thinking abilities, a proactive approach, high motivation, and accountability.
– Exhibit proficiency in the English language, both in speaking and writing documents.
– Exceptions may be considered for individuals who can demonstrate exceptional qualifications.