Varex Imaging Corporation is looking for a Mechanical or Biomedical Engineer- Quality, to support the Field Quality Assurance and Complaint Handling Department to reduce returns and increase customer satisfaction by addressing complaints in a timely manner, and to reduce scrap and increase product quality on a variety of products.
Requirements
- Intermediate Python experience is an added advantage
- Possess strong analytical skills in Data Analysis and Statistics.
- Proficient in the application of recommended Quality Tools such as 5-Why Analysis, Ishikawa (Fishbone) diagram, Fault-tree Analysis, KT Analysis, FMEAs, Control Plans
- Six Sigma Green Belt or Blackbelt is a plus
- Able to read and interpret technical drawings and specifications.
- Proficiency in creating, reviewing, and editing of relevant technical documents and work instructions.
- Able to understand regulatory requirements such as ISO 13485, MDSAP, and EUMDR
Responsibilities
- 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.
- Assist regulatory team during Certification and Customer Audits
- Run cross-functional team meetings in a weekly basis to address quality-related complaints.
- Regulary document complaints in QMS and manage the complaint phases until closure.
Other
- 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.
- Familiarity with MS Office, ETQ, SAP is a big plus.
