Quality Assurance Manager

仕事内容

Responsibilities & Authorities:

Establishes and maintains the QMS, ensuring it is capable of consistently meeting US FDA, EU MDR/IVDR, ISO 13485, TW QMS, other applicable regulations and other customer requirements.

Serves as the Quality Management Representative for Local site for 3rd party and regulatory audits and oversees and excutes quality management review and quality audit processes and reports to Director of Division.

Develops and deploys the quality plan ensuring alignment with QMS, regulatory and customers’ requirements.

Direct and manage Quality Team for quality oversight or execution of the quality assurance assurance in different sites and quality control activities in local site for all projdcts during the product lifecycle and the associated Quality System.

Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.

Manages the CAPA process and review board for ensuring all employees associated with CAPA action items have the capabilities and resources to complete their assignments.

Direct team member and manage processes for deviations, risk assessments and nonconforming material reports.

Handle and manage product RMA, complaint process, inquiry requests or investigations in accordance to client or regulator’s requirements.

Oversees and supervises the change control process and approval.

Responsible for the assigned projects as the QA representative to support the business to ensure the design control process, relevant activities, and design history files (DHF) are in compliance with internal QMS and regulatory requirements.

Engages with and influences the management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.

Ensures the facility process validation system is executed appropriately and maintains compliance to medical device expectations and master validation plans.

For the assigned manufacturing sites, ensures finished product shipped from the facility conforms to the Finished Product Specification and Compliance of Certificate (CoC) for product release and is documented in a device history record. Has authority to hold non-conforming or potentially non-conforming product.

Ensures incoming materials meet raw material specifications with the authority to reject nonconforming raw materials. Communicates material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.

Ensures that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run to target methodologies.

Other duties as assigned.