Provide support on customer problem resolution to Customer Service
Test, calibrate, maintain and repair electrical, mechanical, analytical and electronic devices for conformance
Support ongoing improvements in customer feedback, inventory accuracy, inspection responsiveness and returns processing
Assist in evaluation of field failures to determine failure mode and root cause
Execute quality assurance activities related to equipment/fixture/process/product verification and validation
Audit suppliers as well as internal areas to quality system requirements, including ISO-13485 and 21 CFR 820, among others.
Serve as a resource for production floor personnel
Update quality metrics as assigned
Perform non-routine technical assignments of substantial variety and complexity
Formulate/ helps formulate specifications, quality assurance policies, and procedures
May conduct training on quality assurance concepts and tools
You Have (Requirements):
Bachelor’s Degree in Engineering preferably
6 years of quality experience
Ability to exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining optimal results
Knowledge of Microsoft Office including Excel, Word and Outlook
Ability to read/understand product drawings and inspection plans
You Also Have (Additional):
Minitab and ERP systems experience
Validation and product development of medical devices experience
Specialized advanced courses in the quality field
Professional quality certification
Competencies:
Leadership
Communication – promoting a collaborative environment
Critical thinking and problem solving - the ability to understand the Big Picture
Decisiveness (willingness to exercise ongoing prudent judgment with due care and precision)
Compliance (attention to detail and accuracy, ethics)
Time Management (high degree of self-motivation and organization)
Quality and Safety Focus
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.