Manager, QA Engineer - (Department of Surgery)
Posting Number: req11743
Location: UAHS - Tucson
Address: 1501 N Campbell Ave, Tucson, AZ 85724 USA
Position HighlightsThe mission of the University of Arizona Department of Surgery is to foster excellence in patient care, surgical education, research, and technical innovation. We strive to be leaders and role models of excellence, innovation, and caring in all that we do, and we are committed to train the next generation of surgeon leaders. Our actions exemplify our core values of compassion, integrity, respect, pursuit of knowledge, responsibility, and diversity. The Department of Surgery is seeking an Quality Assurance Engineer to assist other engineers and researchers with medical device development. The successful candidate will oversee and maintain local, state, and federal regulations which may include but is not limited to 21CFR 820.30, ISO 13485 and other relevant medical device standards. The candidate may also provide training and direction to staff. For an overview of our research, please check out this video https://youtu.be/zYEHmx9xLw4.
Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state and optional retirement plans; access to UA recreation and cultural activities; and more!
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Duties & Responsibilities
- Analyze quality standards for components, materials, or
- Apply measures, sampling methods, testing methodology, and other procedures that ensure that quality standards are met.
- Apply quality principles, analyze quality records,
prepare reports, and recommend improvements
- Identify and address recurring problems either with the
quality of the product or the reliability of testing procedures.
- Document quality issues and performance measures for
- May liaise with external vendors.
- Monitor safety of
personnel and equipment/products both for compliance with safety plan and
to identify safety risks and their mitigation.
- Design and develop test procedures, methods, tooling,
fixtures, and processes to verify, validate, or assess device quality.
- Assist in writing and revising standard operating
- Develop product assurance procedures for products
- Monitor implementation of procedures, oversees
revisions, and reports non-compliances to Program Manager.
Knowledge, Skills, and Abilities
- Knowledge of a QMS/Design Control compliance for a Class 3 medical device and/or combination medical product.
- Knowledge of Class VI medical device materials.
- Bachelor's degree or equivalent advanced learning attained through professional level experience required.
- Three (3) years of relevant work experience is required.
Full Time/Part Time: Full Time
Number of Hours Worked per Week: 40
Job FTE: 1.0
Work Calendar: Fiscal
Job Category: Research
Benefits Eligible: Yes - Full Benefits
Rate of Pay: DOE
Compensation Type: salary at 1.0 full-time equivalency (FTE)
Career Stream and Level
Type of criminal background check required: Name-based criminal background check (non-security sensitive)
Number of Vacancies: 1
Contact Information for Candidates
Michelle Guevara | firstname.lastname@example.org
Open Until Filled: Yes
Documents Needed to Apply: Resume and Cover Letter
At the University of Arizona, we value our inclusive climate because we know that diversity in experiences and perspectives is vital to advancing innovation, critical thinking, solving complex problems, and creating an inclusive academic community. As an Hispanic-serving institution, we translate these values into action by seeking individuals who have experience and expertise working with diverse students, colleagues, and constituencies. Because we seek a workforce with a wide range of perspectives and experiences, we provide equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or genetic information. As an Employer of National Service, we also welcome alumni of AmeriCorps, Peace Corps, and other national service programs and others who will help us advance our Inclusive Excellence initiative aimed at creating a university that values student, staff and faculty engagement in addressing issues of diversity and inclusiveness.