About Us: We are a leading In Vitro Diagnostic (IVD) manufacturer committed to delivering high-quality diagnostic solutions worldwide. We are seeking a dedicated and detail-oriented QA Engineer to join our team and support our quality assurance processes to ensure compliance with regulatory requirements and international standards.
Key Responsibilities:
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of production equipment to ensure compliance with quality and regulatory requirements.
- Conduct incoming product and component quality control (QC) inspections to verify compliance with established specifications and standards.
- Prepare and maintain documentation related to quality assurance activities, including IQ/OQ/PQ reports and incoming QC records.
- Collaborate with international distribution partners to prepare and submit relevant registration documents, ensuring compliance with regulatory requirements in various global markets.
- Work closely with cross-functional teams, including production, engineering, and regulatory affairs, to address quality-related issues and implement corrective and preventive actions (CAPA).
- Support audits and inspections by regulatory bodies and customers by providing necessary documentation and ensuring compliance with quality management system (QMS) requirements.
- Assist in the development and implementation of standard operating procedures (SOPs) and quality control processes to enhance product quality and reliability.
- Participate in continuous improvement initiatives to optimize manufacturing processes and maintain high-quality standards.
Qualifications:
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biotechnology, or a related field.
- Minimum of [Insert Years] experience in quality assurance within an IVD or medical device manufacturing environment.
- Strong understanding of IQ/OQ/PQ protocols and quality control processes for incoming materials.
- Experience with international regulatory requirements for IVD products, including FDA, ISO 13485, and other applicable standards.
- Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
- Strong communication and collaboration skills to effectively work with internal teams and international partners.
- Proficiency in quality management systems (QMS) and regulatory documentation preparation.
Preferred Qualifications:
- Multi-lingual proficiency in both Mandarin Chinese and English at a professional level.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.