quality assurance engineer
2 weeks ago
Responsibilities
· Implements Organization's Quality Management System (QMS) and Safety Management System to ensure compliance to regulatory requirements.
· Review & revise Regulatory Exposition Documents, Company Quality Policy, and Quality Procedures including the scope of work & capability list periodically as necessary.
· Maintain and sustain the effectiveness of ISO-certified.
· Schedule and perform internal audit activities including management of internal audit team, pre-audit planning, audit execution, evaluation and post-audit follow-up and recommendations.
· Track and monitor quality KPIs and perform trend analysis to identify systemic improvement opportunities.
· Act as the main point of contact for all QA-related issues and questions from internal teams and external partners.
· Function as Complaint Coordinator to ensure complaint/feedback been addressed and documented for closure.
· Conduct System, product and process audits to ensure regulatory/customer requirements compliance. Drive Corrective Action Request (CAR) prompt closure with effective Corrective and Preventive actions.
· Responsible for in-coming, in-process and out-going processes, ensuring product meets specification.
· Collaborate with Production, Sales and other stakeholders to ensure product requirements are clearly understood and met.
· Supervise work activities of team members to meet customer quality requirements.
· Provide guidance and mentorship to inspectors and ensure adherence to QA process and standards.
· Review the authorisation of certification on a yearly basis to determine the competency of technical personnel and inspectors.
· Perform any other duties as directed by the Quality Assurance Manager.
Requirements:
· Diploma or Bachelor Degree in Engineering or related field.
· Ability to read engineering drawings and use a variety of precision testing and measuring instruments.
· Knowledge of industry regulations and standards (e.g., ISO, FDA, etc.).
· Strong Leadership, & interpersonal skills.
· Responsible, Positive Attitude, Ability to work well in a team
· Fresh graduates may be considered.
Tell employers what skills you haveFDA
Quality Management
Quality Assurance
Interpersonal Skills
ISO
Test Cases
Test Automation
Trend Analysis
Mentorship
Customer Quality
Audits
Selenium
Regulatory Requirements
Java
Audit
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