WHK Quality Engineer

SALARY:

$80,000 - $100,000

SUMMARY
The candidate will establish and maintain the quality assurance program to ensure that the products and the quality system are in compliance with cGMP practices, ISO 13485 requirements and local government and company procedures. The candidate will also provide inter-departmental support by resolving quality issues in a timely manner, establishing and maintaining quality documentation, performing validations, participating in audits and facilitating continuous improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Provide resolutions to non-conformances resulting from internal and external processes.

Perform validations (IQ, OQ, PQ) for WHK infrastructure.

Perform internal audits and facilitate second party and third party audits.

Utilize problem solving techniques such as fishbone diagrams and 5-whys to assist the team in performing Root Cause investigations.

Implement Preventive and Corrective Actions in a timely manner.

Maintain and review Quality Metrics and KPIs. Perform trend analysis and identify action plans.

Assist in the creation, review and approval of procedures, specifications, inspection plans and quality records.

Communicate quality or compliance concerns with urgency.

Assist the Quality Manager in processing rejects and returns by utilizing Epicor ERP.
Collect data and execute/conduct various analytical/statistical analyses and interpretation as part of process improvements and day-to-day support.

Assist the Quality Manager in training personnel.

Report improvements to management and appropriate cross-functional teams.

Teamwork is essential for TSE’s continued success, so Teamwork is an essential function of every employee’s job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. With Teamwork, we all succeed. Without it, we all suffer. Teamwork with co-workers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed. WE ARE TSE.