Quality Calibration Technician
Careers that Change Lives
Impact patient outcomes. Come for a job, stay for a career.
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
PATIENT MONITORING focuses on improving outcomes associated with respiratory compromise, deep vein thrombosis, nutritional insufficiency, and healthcare associated infections.
A Day in the Life
The Quality Calibration Technician develops and manages the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines
ESSENTIAL FUNCTIONS :
Service Calibration:
* Coordinate/ship/receive all Calibrated Assets and ensure they maintain current calibration
* Work with 40 FSE’s to replace broken or due equipment in the field
* Calibrate FSE Torque Drivers
* Maintain an Equal dispersion of field equipment
* Maintain program compliance and report Key Performance Indicators (OOTs) to the CAB
R&D Calibration:
* Handle the annual budget, pay for calibration costs, as well as repairs, and new equipment purchases
* Perform the monthly EHS lab inspections
* Maintain the HAZMAT for all R&D Labs to ensure compliance to applicable standards
* Maintain the ESD Program, perform quarterly work station audits, and annual verifications
* Maintain all active assets (900+) to ensure they are current on calibration and available for use in formal testing
* Maintain an active inventory of all assets with their location and recall them on a monthly basis when they are due
* Work with Simco and other vendors to ensure our calibration standards are being met
* Review all cal certs for accuracy, keep database updated
* Maintain/update all associated procedures
* Report KPI’s to the CAB on a monthly basis
* Work with Engineers and QA on OOT reporting
* Support audits
* Maintain Autoclave (weekly burn-in and flush)
Department specific/ non-essential functions:
* Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix.
* Other duties as assigned with or without accommodation.
MUST HAVE: Minimum Requirements:
Education / Experience:
Minimum of 4+ years of relevant experience and may require vocational or technical education or certification in addition to prior work experience
Skills/Qualifications:
Calibration experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive.
Formal training in CAPA compliance & Investigation techniques.
Risk Manangement, ISO 14971, FTA, Design FMEA,
Comparative Statistical techniques & sampling plans.
NICE TO HAVE:
Preferred
Skills/Competencies:
Previous experience working in a cross-functional team environment.
Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
Familiar with IEC 60601 and product specific industry standards.
DFSS / Lean Green Belt or Black Belt
Other Skills:
Computer literate and experience with PCs, networks, and applications
Some travel required
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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 Day in the Life 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.
EEO
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.uscis.gov/e-verify/employees