Quality Specialist - Medical Devices with ref.

Our client is a global leader in cardio devices and critical care products.

Responsibilities:

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established company standards and agency guidelines
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines
Ensures the quality assurance programs and policies are maintained and modified regularly
Support and manage quality management systems operation within the company
Provide support for design, execution and maintenance of quality system processes at respective departments.
Comply all activities with corporate policies as well as departmental procedures
Implement and maintain Label Management Process and Over-Labeling Process at 3PL, to eliminate Quality Risk related to Local Over-Labeling Activities
Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, Over-Labelled Products, and Returned Products
Manage the Supplier Quality metrics such Supplier Corrective Action Requests (SCAR), Corrective Action and Preventive Action (CAPA)
Initiate and follow-up Supplier Corrective Actions (SCAR) in partnership with Manufacturing Engineering to ensure complete and effective root cause analysis and corrective action implementation.
Provide suggestions to improve 3PL Quality Management System to meet Quality Agreement requirements

Experiences:

Bachelor's Degree or equivalent related field 3 years previous related experience
2 year of experience in a quality and/or manufacturing environment in the medical device industry preferred
Good computer skills in MS Office Suite
Good written and verbal communication skills including negotiating and relationship management skills

Please contact Ewen Poh at +65 6435 5616 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.