QA - Audit Engineer

Job Overview

The QA Audit Engineer is responsible
(a) To support risk-based approach audit events including audit preparation, audit awareness training and verify effectiveness of CAPA process.
(b) Assures microbiology lab maintenance and quality system are compliance with Good Manufacturing Practice and Good Laboratory Practices per applicable regulatory requirement. The role reports to QA Audit Manager located in Quality department, Taiwan.

Main Responsibilities

1. Responsible for audit preparation, coordinating and organizing internal/external audits:
• Assist in development of audit plan, audit schedules, audit report and follow-up audit findings till closure
• Support the site corrective and preventive actions process
• Collect & analyses data analysis for internal/external audit performance
• Training employees on GxP and quality standards and procedure to ensure audit readiness
• Maintaining documentations and procedures within the QMS
• Keep abreast of industry standards and regulations

2. Responsible for microbiology lab & cleanroom requirements are met.
• Work with cross department in biocompatibility assessments, protocols, and reports according to applicable regulatory requirement
• Support cleanroom installation and qualification activities including protocol and report reviews and write-up
• Establish Maintain procedure related to microbiology lab management, environmental monitoring, sterility assurance and contamination control
• Support in non-conformance pertaining to environment control, product cleanliness and sterility assurance related investigation, corrective/preventive actions implementation with cross department

3. Carry out other duties as assigned by the supervisor or management.

Skills and Qualification

• Bachelor’s Degree in Engineering, microbiology, manufacturing ,technical discipline, other related science is required
• Minimum 3 years’ experience in Quality Assurance related function, Medical Device, Bio-Pharmaceutical or other regulated industry
• Familiar with 21 CFR 820, ISO13485, cGMP, cleanroom requirement, bio-contamination control & sterilization is preferred
• Trained internal auditor in ISO 13485 / ISO 9001 or equivalent will be an added advantage.
• Experience in managing external quality audit will be an added advantage.
• Knowledge of Quality Tools, auditing technique, problem solving skills is preferred.
• Able to work well in a cross functional team and manage your own job load independently
• Well-versed in English and Chinese, read, written and communicate
• Attention to details, keen interest in compliance and continual improvement matters