Job Description

Job Duties: \xe2\x97\x8f Work with all functional teams closely to develop and optimize the process based on ISO 13485:2016 and internal operation\'s needs. \xe2\x97\x8f Maintain good documentation and record under the quality management system. \xe2\x97\x8f Make sure whether the product goes through auditing and testing. \xe2\x97\x8f Formulate timely reports and documentation to track progress. \xe2\x97\x8f Supervise inspection, science-based testing activities, administer proficiency tests, and annual training at all process stages, including batch/lot production, assembly, quality testing, and shipping. \xe2\x97\x8f Participate in the strategic planning process. \xe2\x97\x8f Constantly review all annual reports and recommendations on the Quality Assurance Program to decide areas of improvement, change and deletion of processes, procedures and documentation related to efficiency and quality. \xe2\x97\x8f Liaise with external agencies and customers on matters of quality. \xe2\x97\x8f Ensure that all staff performing incoming, in-process and final inspections are trained in their responsibilities and have sufficient and adequate tools equipped. \xe2\x97\x8f Make recommendations for improvements in all processes. \xe2\x97\x8f Record and organize all necessary documentation for implementation, maintenance and effectiveness of the quality control programs. \xe2\x97\x8f Assist with the development and implementation of new quality control programs. \xe2\x97\x8f Monitor daily QC activities and testing performance. \xe2\x97\x8f Apply tools\' interpretation and apply team concepts both as a member and leader to drive. \xe2\x97\x8f Implement and monitor the effectiveness of CAPAs. \xe2\x97\x8f Risk Management during the entire product life cycle. \xe2\x97\x8f Conduct Process Failure Mode and Effect Analysis (PFMEA). \xe2\x97\x8f Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. \xe2\x97\x8f Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. \xe2\x97\x8f Develop and maintain standard operating procedures or local working practices. \xe2\x97\x8f Make documentation of internal audits and quality assurance activities. \xe2\x97\x8f Plan, conduct, and monitor the test, and inspect the products to ensure their quality to meet the quality standards. \xe2\x97\x8f Make sure all the legal standards are met and review thoroughly the existing policies and standards \xe2\x97\x8f Review the organization\xe2\x80\x99s process to ensure whether they align with the current policies Education and Experience: \xe2\x97\x8f Bachelor\xe2\x80\x99s Degree in Engineering, Biology, and Biochemistry related field. \xe2\x97\x8f 8+ year related work experience in biotech, pharmaceutical, in medical devices industries with supervisory experience. \xe2\x97\x8f Having relevant experience in quality inspection, auditing, and testing is an added advantage \xe2\x97\x8f Ample experience in implementing corrective/preventive measures \xe2\x97\x8f Quality assurance knowledge of tools and methodologies \xe2\x97\x8f Certification programs in Six Sigma, Quality Improvement associate, quality auditor, and quality engineer Qualifications: Technical Skills: \xe2\x97\x8f Master in MS Office and relevant applicable computer skills. \xe2\x97\x8f Contain Certificate ISO 13485:2016 and with the ability to operate and coordinate the annual auditing smoothly. Soft Skills: \xe2\x97\x8f Entry level of leadership skills with the ability to give basic supervision to the department employees in daily operations. \xe2\x97\x8f Outstanding prioritization skills and the willingness to be responsible for multiple tasks in the same time. \xe2\x97\x8f Excellent interpersonal skills and willingness to work under pressure. \xe2\x97\x8f Strong analytical and problem-solving skills with the ability to pay close attention to details. \xe2\x97\x8f Excellent time management skills with the ability to meet deadlines. \xe2\x97\x8f Willingness to work in a collaborative working environment. Preferred: \xe2\x97\x8f Project management skills \xe2\x97\x8f Mandarin, Chinese Job Type: Full-time Benefits:

• Extended health care

Flexible Language Requirement:

• French not required

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Burnaby, BC V5J 5H6: reliably commute or plan to relocate before starting work (required)

Experience:

• quality assurance: 1 year (preferred)

Work Location: In person