· Provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company

· Represents Quality as a team member to support new product development/introduction activities

· Supports the manufacturing line to address quality issues and resolution. Investigate and troubleshoot product or production issues.

· Promotes awareness of Quality and Regulatory requirements

· Leads or participates in the development of process and procedure development/changes

· Develops process control methods and, as applicable, applies statistical process control (SPC) methods to evaluate current processes and process changes

· Supports validation and verification strategy for new and existing products and processes as assigned

· Leads the development and maintenance of Master Validation Plans

· Participates in the CAPA process as required as an assignee or project team member

· Investigates escalated product complaints to root cause to ensure timely customer response and correction

· Monitors product and process performance metrics and acts upon trends (positive or negative)

· Serves as MRB team member to ensure proper disposition of non-conformances

· Authors, reviews, and approves Quality System documentation including change orders, DHF documents, DMRs, and DHRs

· Support supplier quality team as needed as an SME in supplier qualification audits•

· Interfaces with suppliers and customers to resolve Quality issues

· Develops sampling plans

· Develops and drives measurable Quality improvements relating to products and processes

· Ensure Inspecting and Testing of materials, equipment, processes, and products to meet quality specifications.

· Create test and inspection method and develop and execute test method validations

· Collaborate to develop and implement quality and process controls and improvements.

· Assure the QMS conforms to the customer, internal, industry (i.e., AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements.