Quality Engineer [ISO 13485, Medical Equipment, Root Cause Analysis]

Job Responsibilities:

1. Collaborate with internal and external customers to provide timely support for inspection, testing, process capability, qualifications/validations, GRR, Minitab analysis, FAI analysis, and inspection planning.

2. Review and update work instructions related to inspection techniques and equipment, working closely with Engineering to meet metrology requirements.

3. Lead the management of nonconforming materials and products, including disposition, investigation, CAPA/corrections, and customer communication.

4. Serve as the Key User and lead for the ERP (Quality) and EQMS systems.

5. Organize and manage both internal and external audits in compliance with ISO 13485 standards.

6. Support quality methodologies for process changes and assist in communicating process changes with customers.

7. Provide training based on expertise, resume, or demonstrated work experience, and ensure training requirements are consistently up to date using a training tracking system.

8. Prepare quality documentation and reports by collecting, analyzing, and summarizing data and trends, including failed processes, stability studies, customer returns, corrective actions, and re-validations.

9. Enhance the department and organization's reputation by taking ownership of new and different tasks, exploring opportunities to add value to job accomplishments.

10. Perform any other duties or projects as assigned by management and the Global Quality Team.

Requirements:

1. BA/BS in an Engineering discipline with 5-7 years of experience, or BA/BS in a scientific discipline with 7-10 years in an engineering or technical role.

2. Preferred experience working in an ISO 13485:2003 and/or ISO 9001:2000 certified environment.

3. Medical device experience is a plus.

4. ASQ-certified Quality Engineer is preferred.

5. Proficiency in utilizing MRP or ERP software, as well as Statistical Analysis Software.

6. Experience with root cause analysis, project management, statistical analysis, SPC, Six Sigma tools, and Geometric Dimensioning and Tolerancing (GD&T).

HOW TO APPLY:

Interested applicants, please click on “Apply Now” and provide the below details in your resume.

We regret only shortlisted candidates will be notified.

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