The QA lead/manager is responsible for all aspects of the Quality Management System (QMS), facilitating quality minded company culture and ensuring processes, products and services meet all external and internal quality requirements and are in compliance with regulations. The QA lead/manager interacts with all functions and levels throughout the company and outside the company working in an international, multidisciplinary and multi-project environment.
RESPONSIBILITIES:
· Directly responsible for QMS activities including CAPA Process, Complaints, Manufacturing Deviation (NCRs), Change Control, Document Control, Internal Audits, Supplier Qualification and QA Training
· Responsible for implementation, support, and maintenance of computer systems used for QMS processes
· Support the development and implementation of all QMS processes and procedures across company, including but not limited to; Design and Development, Risk Management, Purchasing & Supplier Quality, Process Control, Identification and Traceability, and Servicing
· Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement
· Collect, analyze, and present data on the QMS status during Quality and Management Review Meetings
· Representative for audits from external regulatory authorities and registration agencies
· Assist with development, deployment, and execution of Quality Policies, Quality Objectives, and Quality Plans
· Responsible for supplier qualification and audits
REQUIREMENTS
· Bachelor’s degree a must, formal education in Quality – an advantage
· At least 5 years of experience in Quality Assurance in medical device development and manufacturing environment, including exposure to FDA/ISO regulations (and standards such as ISO 13485, ISO 14971, 21 CFR 820/211, and MDD/MDR)
· Must have experience in developing, implementing, and maintaining effective Quality System Processes
· Must have experience in leading or participating in audits
· Experience in writing procedures, creating management level presentations and reports
· Prior experience with international companies – an advantage
· Assertiveness – capable of promoting changes
· Detail oriented, organized and methodical
· Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly
· Strong verbal and written communication skills in English – mother tongue level
· Lead auditor/qualification as an internal auditor – an advantage
· Prior hands-on experience with QA for manufacturing – an advantage
