Varex Imaging Corporation
Mechanical Or Biomedical Engineer- Quality
Varex Imaging Corporation is a leading innovator, developer, and manufacturer of X-ray imaging component solutions. With a 65+ year history of successful innovation, Varex Imaging is looking for a motivated and proactive Mechanical or Biomedical Engineer- Quality to support Varex Field Quality Assurance and Complaint Handling Department. The group helps reduce returns and increase customer satisfaction by addressing complaints in a timely manner. There are always interesting and challenging opportunities in production and engineering that require us to work together as a team and leverage each other's experience. 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. Assist regulatory team during Certification and Customer Audits 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. Familiarity with MS Office, ETQ, SAP is a big plus. 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 Time Type: Full time Job Type: Regular Work Shift: First Shift Pay Rate Type: Salary Benefits and Perks: Medical Insurance Dental/Vision 10 Paid Holidays PTO Employee Stock Purchase Plan 401K match Paid Parental Leave Short & Long-Term Disability and Life Insurance Competitive Pay Flexible Schedules Variety of Shift Options Free Safety Shoes Friendly Work Environment On-site Cafeteria, Company Nurse, Credit Union, and Gym Free Coffee and Soda Tuition Reimbursement Employee Referral Program Career Advancement Opportunities Employee Discounts EV Charging Stations All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Varex Imaging Corporation is a leading innovator, developer, and manufacturer of X-ray imaging component solutions. With a 65+ year history of successful innovation, Varex Imaging is looking for a motivated and proactive Mechanical or Biomedical Engineer- Quality to support Varex Field Quality Assurance and Complaint Handling Department. The group helps reduce returns and increase customer satisfaction by addressing complaints in a timely manner. There are always interesting and challenging opportunities in production and engineering that require us to work together as a team and leverage each other's experience. 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. Assist regulatory team during Certification and Customer Audits 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. Familiarity with MS Office, ETQ, SAP is a big plus. 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 Time Type: Full time Job Type: Regular Work Shift: First Shift Pay Rate Type: Salary Benefits and Perks: Medical Insurance Dental/Vision 10 Paid Holidays PTO Employee Stock Purchase Plan 401K match Paid Parental Leave Short & Long-Term Disability and Life Insurance Competitive Pay Flexible Schedules Variety of Shift Options Free Safety Shoes Friendly Work Environment On-site Cafeteria, Company Nurse, Credit Union, and Gym Free Coffee and Soda Tuition Reimbursement Employee Referral Program Career Advancement Opportunities Employee Discounts EV Charging Stations All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.