Position Summary: The Quality Engineer provides the technical leadership for the development, maintenance, and improvement of all quality systems. This includes Final Inspection, In-Process Controls, Supplier Quality Assurance, Systems Auditing, Product Testing, and Finished Goods Audit. Will measure and report quality performance and ensure conformity to engineering and quality standards.
Essential Responsibilities: (other duties as assigned)
Lead corrective and preventive action teams
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
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Competencies:
Commitment/Dependability
Integrity
Communication – promoting a collaborative environment
Collaboration
Attention to Detail/Quality of Work
Leadership
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
Qualifications:
Bachelor's Degree in Engineering or Quality related field desired
3+ years of Quality experience desired
Experience with a manufacturing environment preferred
Ability to exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining optimal results
Knowledge of Microsoft Office including Excel, Word and Outlook required
Knowledge of Minitab and ERP systems preferred
Solid statistical knowledge and practical experience
Ability to read/understand product drawings and inspection plans
Strong project management, team leadership/process skills and experience
Validation and product development of medical devices experience preferred
Specialized advanced courses in the quality field preferred
CQM, CQE, or CQA certification desired
Demonstrate Brewer's core values of Learning, Innovation, Integrity, and Collaboration
Regular and consistent attendance
Physical / Mental Demands:
Lifting up to 10 pounds occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
The worker is not substantially exposed to adverse environmental conditions
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading
The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
Working Environment: Office / Manufacturing Floor / Warehouse
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.