Controlled Environment Area Quality Assurance Technician

Medtronic

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profile Job Location:

Tempe, AZ - USA

profile Monthly Salary: $ 58000 - 87000
Posted on: 06-11-2025
Vacancies: 1 Vacancy

Job Summary

We anticipate the application window for this opening will close on - 14 Nov 2025


At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Are you passionate about ensuring the highest standards of quality in a dynamic and innovative environment Join our team in Tempe AZ as a Controlled Environment Area Quality Assurance Technician! We are seeking a Technician who will be helping managing quality validations and documentations around controlled environment areas (CEA) and production equipment. The ideal candidate will be self-sufficient and help manage CEA validations excursion product disposition and manage the software systems around CEA monitoring (particle temperature humidity)

Responsibilities may include the following and other duties may be assigned.

  • CEA Validation and Testing: Support the CEA validation and annual re-qualification process. Validation plan and report to document Contractor provided data.
  • CEA monitoring (TemperatureHumidity): Monitor analyze and continuously improve the performance of temperature and humidity work with Facilities to predict potential failure. You will own the monitoring data and the calibration management of the sensors.
  • CEA monitoring (Particulates): Monitor analyze and continuously improve the performance of temperature and humidity work with Facilities and Operations to understand excursion root cause. Drive documentation to asses product impact when excursion occurred. You will own the monitoring data and the calibration management of the sensors.
  • Production equipment validation: Support Maintenance and Facilities data collection to help equipment validation.
  • Collaboration: Work closely with product owners process engineers Facilities Quality and Operations to ensure data and CEA are audit ready every day.
  • Documentation and Compliance: Maintain thorough process documentation and ensure adherence to relevant industry standards and compliance regulations (e.g. ISO 14644 and global regulatory requirements).

      Required Knowledge and Experience:

      Requires minimum of 4 years of relevant experience.
      Requires high school diploma or equivalent

      Preferred Knowledge and Experience:

      • Ability to write quality technical documents.
      • Ability to use sensors flow meter read gauges to support validations.
      • Associates degree or higher in Electronics Mechanical Engineering Technology Biomedical Engineering or a related technical field.
      • NEBB certification.
      • Participate in and support audits.
      • Ability to read test results from equipment and vendors
      • Respond to environmental alarms
      • Interact with computer-controlled sensors recording date
      • Coordinate investigation with operations teams
      • Knowledge of ISO 14644 for Controlled Environments and ISO 14698 for Bio Burden in Cleanroom Control.

    Physical Job Requirements

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

    Benefits & Compensation

    Medtronic offers a competitive Salary and flexible Benefits Package
    A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

    Salary ranges for U.S (excl. PR) locations (USD):$58000.00 - $87000.00

    This position is eligible for a short-term incentive called the Operations Incentive Plan (OIP).

    The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

    The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

    The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

    Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

    Further details are available at the link below:

    Medtronic benefits and compensation plans

    About Medtronic

    We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
    Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
    We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

    Learn more about our business mission and our commitment to diversity here.

    It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

    If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


    Required Experience:

    IC

    We anticipate the application window for this opening will close on - 14 Nov 2025At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected c...
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    Key Skills

    • Quality Assurance
    • Coordinate Measuring Machine
    • Food Industry
    • Food Safety Experience
    • ISO 9001
    • Math
    • Food Processing
    • Quality Control
    • cGMP
    • QA/QC
    • HACCP
    • Manufacturing

    About Company

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    About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more

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