Quality Engineer

Mechanical Or Biomedical Engineer- Quality

Varex Imaging Corporation is a leading innovator, developer, and manufacturer of X-ray imaging component solutions. With a history of successful innovation, our components are used in medical, industrial, and security imaging applications worldwide. Our mission is to improve and save lives by making the invisible visible. Our values of Excellence, People, Innovation, and Customer are foundational to our success. We are looking for a Mechanical or Biomedical Engineer- Quality to support Varex Field Quality Assurance and Complaint Handling Department.

Job Description:

Varex Imaging is looking for a Mechanical or Biomedical Engineer - Quality, for the following functions:

- Lead multi-disciplinary team to resolve internal and external Quality issues

- Monitor Product Quality Performance on a regular basis

- Conduct Post Market Surveillance activities and generate Periodic Safety Update reports to ensure that Varex is compliant to regulation

- Provide weekly reports to management involving customer issues, volume, and nature of complaints.

Essential Duties and Responsibilities:

* Run cross-functional team meetings in a weekly basis to address quality-related complaints.

* Regularly document complaints in QMS and manage the complaint phases until closure.

* Support RAQA organization in the containment, investigation, and closure of customer complaints in a timely manner.

* Daily monitoring of Quality Assurance inbox to ensure complaints are logged in the QMS database and resources assigned.

* Collaborate with Supplier Quality, Internal Quality, Process Engineering, and Design Eng teams to resolve quality issues.

* Ensure that the factory is compliant to ISO 13485:2016, MDSAP, and EU MDR requirement by conducting internal audits.

* Track volume and cycle time of customer complaints from start to finish. Assist the team to resolve delays and constraints.

* Prepare Quality Report updates and present to customer during regular meetings and telecons.

* Prepare 5D/8D reports and facilitate meetings to address quality issues.

Required Knowledge, Skills, And Abilities:

* B.S. degree in Mechanical or Biomedical Engineering

* 2+ years of QA Engineering or Process Engineering experience

* Articulate and fluent in both written and spoken English.

* Intermediate Python experience is an added advantage

* Possess strong analytical skills in Data Analysis and Statistics.