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Summary
Varex Imaging Corporation is a leading innovator developer and manufacturer of X-ray imaging component solutions which includes X-ray tubes digital flat panel detectors software and other key components of X-ray imaging systems. With a 65 year history of successful innovation you will find our components in countless medical industrial and security imaging applications worldwide. Our mission states that through the talent of our people and vision of customers we help improve and save lives throughout the world by making the invisible visible. Our values of Excellence People Innovation and Customer are foundational to our success in upholding our mission. We cannot make the invisible visible and uphold our mission without our EPIC employees who deliver cutting edge technology globally consistently pursue the highest quality standards inspire innovation and showcase a customer mindset.
Varex Imaging is looking for a motivated and proactive Mechanical or Biomedical Engineer- Quality to support Varex Field Quality Assurance and Complaint Handling Department. Our group helps reduce returns and increase customer satisfaction by addressing complaints in a timely manner. Our group also helps reduce scrap and increase product quality on a variety of products ranging from Medical to Industrial applications. There are always interesting and challenging opportunities in production and engineering that require us to work together as a team and leverage each others 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.
- Regulary 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
Varex Imaging provides competitive pay and benefits to support the financial physical and emotional well-being of the people who make our company successful.
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.