Summary of Function:

The Quality Engineer II (QE II) is responsible for quality activities in support of Production and Engineering activities at Medbio.

The QE II is responsible for quality management system activities, including maintaining compliance to ISO/FDA requirements. The

QE II is a mid-level engineer that requires some guidance and is able to lead some activities.

Major Duties and Responsibilities:

1. Assist with responsibilities of any other members of the Quality Department as needed.

2. Train Medbio personnel on quality documents and processes

3. Develop relationships with other departments with the goal of instructing and communicating quality requirements to ensure a

high quality product and compliance to all aspects of the Quality Management System

4. Nonconforming material report (NMR) activities including tracing nonconforming conditions back to their origin, confirming

containment activities properly segregated potentially non-conforming material, leading determination of root cause and

appropriate corrective action, completing NMR documentation, approving, and escalating to a CAPA when appropriate

5. Develop relationships with customers for assigned customers / parts, including at least one major customer

6. Show advanced level of understanding of customer parts and applications

7. Serve as a member of the Customer Focus Team (CFT) for assigned customers / parts, frequently leading team efforts

8. Serve as customer contact for discrepant product issues identified at the customer or at Medbio

9. Work with customer to solve any specification concerns during development and after release to production

10. Work with customers and project engineers to determine and execute the quality planning process through to product launch

and any changes once products have been released to production

11. Communicate with customers regarding changes in manufacturing methods (CIMMs)

12. Participate in equipment and software validation and mold qualification as needed, including writing protocols, executing

requirements, and writing reports

13. Assist in setting lab priorities and division of responsibilities

14. Serve as a resource for basic statistics skills

15. Create and analyze statistical experiment plans as needed, including Gage R&R, Measurement System Analysis, Process

Study, Tolerance Interval, etc.

16. Serve as a resource for part measurement issues, including spec interpretation, measurement techniques, vision system

programming, etc.

17. Coordinate sample submissions (PPAP, approved samples)

18. Approve defect samples

19. Support business development for new and existing customers when opportunities exist

20. Complete all required documentation, legibly and accurately, on paper and electronically in computer systems using proper

grammar

21. Complete documentation (batch record) review related to FDA regulated medical devices and components as outlined in

“product release” planning sheets

22. Develop and maintain ISO and FDA compliant quality documents related to products and quality processes, including

inspection plans, work instructions, traveler documentation, SOPs, and forms. Assist other departments with their documents.

23. Perform and analyze process capability and tolerance interval studies, determining course of action for any outlier,

unexpected, or failing results. Write reports and communicate to customer, receiving approval as needed.

24. Lead or participate in internal audits and support external audits as requested

25. Lead or participate in supplier audits as requested

26. Lead one or more of the following (may participate in multiple):

26.1. Internal Audit program

26.2. CAPA Team

26.3. Monthly Metric preparation

26.4. Intellect module development or modification

26.5. Equipment or Software validation

27. Lead major supplier quality issue

28. Maintain a professional relationship with all other employees, and develop strong team relationships

29. Keep a clean and orderly work area, including proper filing and maintenance of QA documentation and samples

30. Learn and follow ISO/cGMP requirements, ensuring that the procedures and systems at Medbio are in compliance, and

maintaining a high level of awareness of the requirements among the employees at Medbio

31. Work to achieve Monthly Company goals and metrics

32. Function as a designate for the Quality Manager or other Quality Engineers as requested

33. Perform other tasks assigned by the Quality Manager

34. Maintain work habits and safety procedures according to company policy, standard operating procedure, and quality manual

35. Support and adhere to Medbio’s Corporate Mission and Core Values

36. Perform other duties as assigned

Organizational Relationships:

The QE II reports to the Quality Manager. Management, Engineers, Team Leaders, and Technical staffing can look to the QE II for

clear resolution to specification and/or part-quality issues. The QE II interacts with management, engineers, maintenance,

operators, assemblers, suppliers, and customers regarding all aspects of part and process quality.

Experience and/or Educational Requirements:

1. Four-year degree (engineering, science, or similar) plus three to four years of relevant experience required; Advanced degree

a plus

2. Certified Quality Auditor, Certified Quality Engineer, or Six Sigma Black Belt Certification a plus

3. Preferred experience in a medical device manufacturing environment or similarly regulated environment

4. Advanced understanding of ISO/cGMP requirements with regard to manufacturing and document control preferred

5. Good computer skills (Microsoft Office)

6. Advanced math skills

7. Advanced blueprint reading skills with understanding of GD&T principles preferred

8. Moderate understanding of statistics required; Advanced understanding of statistics preferred

9. Strong written/verbal communication, leadership, interpersonal and motivational skills

10. Self-motivation and ability to manage multiple projects with important deadlines

Physical Requirements:

• Must be able to work a standard 40 hour workweek with occasional overtime including weekends a possibility.
• Sitting and/or standing for extended periods of time as well as some walking within the facility.
• Must be able to see with or without corrective lenses and distinguish color differences and depth perception for product
• and safety issues.
• Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet.
• The ability to lift and carry various items up to 30 pounds required
• Pass an audiology screening

Pay: $85,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Military leave
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance

Work Location: In person