Primary Purpose:To ensure all validation and quality control activities are compliant with the regulatory requirement, customer requirement, and internal QMS requirement in new product introduction phase.To ensure all products and process quality can meet Product Specification.Core team member of a project during project launch phase.

Duties& Responsibilities

1.Create and maintain PPAP packages—APQP, PFMA, control plan, SPC, MSA, etc., and submit to customer for approval.

2.Lead medical project process validation and verification and comply with global validation requirements. Create all the related new project validation protocol, reports and align with customer.

3.Create all Quality plan/Inspection instruction for products, and perform the training to the responsible person.

4.Create the SPC method for process control, and perform the training to the responsible person.

5.Create all the record templates for the product inspection activities.

6.Ch...