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.
We are looking for a motivated and proactive Quality Engineer 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 other’s experience.
Responsibilities of our Quality Engineer:
- Lead multi-disciplinary team to resolve internal and external Quality issues.
- Monitor Product Quality Performance on a regular basis and report to the team.
- 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.
- Work closely with other members of the QA organization (internal and external) in order to meet deliverables for a timely closure of complaints.
- Assist regulatory team during Certification and Customer Audits.
Essential Duties and Responsibilities:
- Daily monitoring of Quality Assurance inbox to ensure complaints are logged in the QMS database and resources assigned.
- Support RAQA organization in the containment, investigation, and closure of customer complaints in a timely manner.
- 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 reports and metrics to management.
- 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, & Abilities:
- Bachelor of Science degree in Mechanical, Chemical, Electrical/Electronics, Biomedical, or Applied Physics.
- 2+ years of QA Engineering or Process Engineering experience is preferred.
- 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
- Critical thinker with attention to detail but has a positive attitude.
- 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
BENEFITS Offered to our Employees:
- Medical Insurance (Select Health or Regence)
- Dental/Vision Insurance
- 10 Paid Holidays plus 1 Floating Holiday of YOUR Choice
- A Generous Paid Time Off plan
- Employee Stock Purchase Plan (15% Discount)
- 401K Plan through Fidelity
- Tuition Reimbursement (up to $7,500 per Year)
- Short/Long-Term Disability (Company Paid)
- Life Insurance (Company Paid)
- Annual Bonus potential
- Benefits begin on your first day!!
Take a Look at Our PERKS:
- ON-SITE Cafeteria, Nurse, Credit Union, and Gym
- Free soda & coffee
- Career Advancement Opportunities
- EV Charging Stations
- Secured Parking
- Meaningful work producing life-saving products