Euro 65K - Euro 75K per annum
A Japanese Global manufacturing company is looking for the QA Manager, who will be responsible for managing all QA /QC and RA activities to develop our company growth in Europe.
Duties and Responsibilities
l Responsible for RA activities including product registration, compliance audits preparation and responding.
l Manage and maintain compliance of the company to applicable ISO standard and FDA regulation.
l Accountable for complaints, recall issues, non-conformances and quality issues.
l Facilitate self-inspection and quality patrol on production areas
l Lead the investigation of the root cause and formulation of corrections, corrective action and preventive action.
l Review quality inspection reports and evaluates data to recommend shipment judgment or stoppage of production line if necessary.
l Ensure implementation of CAPA, complete documentation and on time closure.
l Plan and implement methods and techniques for continual improvement of products and processes in order to reduce cost.
l Oversee the compliance of document and data control systems.
l Control quality documents and records, procedures and other GMP-related policies by generating revision or creation as necessary.
l Manage the execution of internal and external audits and ensure timely closure.
l Implement an effective operator training and certification program. Also, manage the conduct of QMS trainings.
l Attend to quality audit of suppliers to verify compliance with set specifications and standards.
l Lead improvement activity and Total Quality Control activities of the organization to success.
l Plan and manage the annual budget
l Report the overall status of Quality Management System in the meeting with Management or in other venues.
l Comply with the regulations such as Walmart, EMC, RoHS, WEEE, REACH
l Provide the directions to shop floor and other QMS activities of the organization.
l Performs other related tasks that maybe assigned by the immediate superior.
l Licensed pharmacist or bachelor’s degree in science, engineering or related field
l 3+ years management experience required.
l 5-7 years’ experience in in a manufacturing particularly in the medical device manufacturing company.
l English business level speaker.
l Strong knowledge of Iso 13485, FDA regulations and other local and international regulatory requirements.
l Excellent decision making skills, strong leadership and communication proficiency
Candidate must be eligible to work without any restrictions as no visa support given