Supplier Quality Engineer-Medical Device

The Senior Supplier Quality Engineer works on behalf of HiARC to provide direction and oversight of HiARC's suppliers.

Work in a team environment with suppliers to develop and implement best practices that emphasize defect prevention, reduction in variation and waste, and provide for continuous improvements in meeting all customer requirements.

Collect root cause analysis and provide corrective feedback to prevent line stops due to supply issues.

Manage the customer-specific requirements and offer technical support to suppliers.

Responsible for ensuring that the products produced meet quality standards required to minimize quality costs and maximize customer satisfaction whilst ensuring that procedures and processes are adhered to.

Maintain the robustness of product builds following new product introductions to ensure continuity and improvement in supplier capability.

Manage the customer-specific requirements and offer technical support.

Work on multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion.

He/she must demonstrate attention to detail, strong Lean Principles, analytical skills, documentation, processes, and excellent verbal / written communication.

PRINCIPAL RESPONSIBILITIES:


* Perform Supplier evaluation audits, supplier support and supplier advanced quality planning (AQP).


* Manage supplier performance by monitoring of quality, delivery, and cost metrics and developing corrective action plans when appropriate.


* Review potential suppliers for acceptability to ASL


* Support the evaluation/classification of suppliers


* Work with the supplier directly to support business requirements: Non-Conforming Material Reports (NCMR's) and Supplier Corrective Actions (SCAR's).


* Facilitate root cause analysis and corrective actions of supplier quality issues, Identify and recommends processes, procedures, and equipment.


* Audit suppliers for root cause analysis and verification of correction actions of supplier quality issues.


* Interact with Supplier to ensure timely Non-Conforming Material Reports (NCMR's) and Supplier Corrective Actions (SCAR's), including effectiveness and verification.


* Work with Design and Manufacturing Engineering teams to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements.


* Supporting complete and accurate documentation of inspection results as defined by regulations, product specifications or Control Plans, Part Approval Process or product warrant submission.


* Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities.


* Promote the use of preferred techniques for continuous improvement such as Lean, Poka-Yoke, Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)


* Provide leadership to identification and deve...