Job Listings

Manager, QA Engineer - (Department of Surgery)

Company:
The University of Arizona
Job Location:
Tucson, Arizona
Category:
Health and Medical Services

Posting Number: req11743

Department: Surgery

Location: UAHS - Tucson

Address: 1501 N Campbell Ave, Tucson, AZ 85724 USA

Position Highlights

The 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!

The University of Arizona has been recognized for our innovative work-life programs. For more information about working at the University of Arizona and relocations services, please click here.

Duties & Responsibilities

  • Analyze quality standards for components, materials, or
    services.
  • 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
    management review.
  • 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
    procedures.
  • Develop product assurance procedures for products
    produced.
  • 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.

Minimum Qualifications

  • Bachelor's degree or equivalent advanced learning attained through professional level experience required.
  • Three (3) years of relevant work experience is required.

Preferred Qualifications

  • Experience with 21CFR820.30 and ISO13485 compliance.
  • FLSA: Exempt

    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)

    Grade

    9

    Career Stream and Level

    PC2

    Job Family

    Research Engineering

    Job Function

    Research

    Type of criminal background check required: Name-based criminal background check (non-security sensitive)

    Number of Vacancies: 1

    Contact Information for Candidates

    Michelle Guevara | mdguevara@surgery.arizona.edu

    Open Until Filled: Yes

    Documents Needed to Apply: Resume and Cover Letter

    Diversity Statement

    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.

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