The QA lead is involved in a broad range of Quality Assurance activities, ensuring processes, products and services meet external and internal quality and regulatory requirements. The QA lead interacts with all functions and levels throughout the company and outside the company working in an international, multidisciplinary and multi-project environment.
The position reports to the QA Director.
RESPONSIBILITIES:
· Involvement in a range of QMS activities such as CAPA Process, Complaints, Manufacturing Deviation (NCRs), Design Control, Change Control, Document Control, Internal Audits, Supplier Qualification and QA Training
· Responsible for implementation, support, and maintenance of computer systems used for QMS processes
· Supports the development and implementation of QMS processes and procedures, quality objectives and plans
· Monitors and audits the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement
· Collects, analyzes, and presents data on the QMS status during Quality and Management Review Meetings
· Participates in audits from external regulatory authorities and registration agencies
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
· Must have experience in developing, implementing, and maintaining effective Quality System Processes
· Must have experience in document and design control
· Must have experience in participating in audits
· Detail oriented, organized and methodical
· Strong verbal and written communication skills in English – mother tongue level
· Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly
· Internal auditor/qualification as an internal auditor – an advantage
· Prior experience with international companies – an advantage
