The Quality Assurance Engineer is responsible for the maintenance and improvement of the Quality System according to FDA, ISO and other related regulations and requirements. This position leads initiatives to develop, implement, and maintain quality assurance standards, processes, policies and procedures to meet customer and regulatory requirements.
ESSENTIAL JOB FUNCTIONS
- Develop, modify, apply and maintain Quality standards and protocols.
- Develop, evaluate, improve and document quality control processes.
- Work closely with engineering team for design controls.
- Conducts Quality Management Systems (QMS) audits and assessments of internal quality systems.
- Coordinates and manages external audits (ISO 13485, FDA, etc.).
- Post market surveillance, including documentation of customer calls, complaints, RMA, etc.
- Manage and support the Material Review and CAPA processes.
- Work closely with Service & Repair functions to develop and document processes to ensure timeliness of Zyno customer satisfaction.
- Supplier management
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
- Bachelor’s Degree. A degree in the area of Biomedical, Electrical or Mechanical Engineering is highly desired.
- Strong Communication skills, oral and written.
- Ability to speak Mandarin Chinese.
- Enthusiastic, cooperative behavior.
- Medical Device industry quality assurance experience .
- Exposure to 21CFR820 Quality System Regulations is required .
- Must be a self-starter and able to work independently with limited supervision.
- Familiarity with ISO 13485 Internal auditing procedures; certification desired. Ability to analyze, measure, develop and maintain continuous improvements of products and processes.