QA Inspector

Job description

This job is for the Medtronic HeartWare Business.

POSITION DESCRIPTION:
The QA Inspector demonstrates quality in all actions; Perform product inspections. Document non-conformances per established SOPs. Review of Device History Record (DHR) documentation for discrepancies / missing information. Assist in implementation of Corrective and Preventative Actions. Execute and document testing in support of QA Engineering. Assist in the Returned Goods process.

POSITION RESPONSIBILITIES:
Acquires job skills and learns Company policies and procedures to complete routine tasks.
• Able to follow established procedures without unapproved deviations.
• Able to review DHR documentation for proper completion and/or discrepancies.
• Familiar with inspection instruments such as micrometers, calipers, pin gages, etc.
• Able to properly communicate (written & orally) inspection results.
• Able to work with returned used product in a Biohazard  Environment.
• Available to work after-hours and weekends.
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 exciting and rewarding place to be.
We can 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 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.

EEO STATEMENT:
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. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Desired profile

BASIC QUALIFICATIONS:
• Strong computer skills in MS Office products
• Must be hands-on and highly service-oriented
• Must be able to utilize inspection tools
• Must be able to perform visual inspection
• Must be able to write, read and speak effectively in English
• Must be able to interact with manufacturing associates, manufacturing supervisors, technician and engineers
• Must be able to ingress and egress a controlled environment area without assistance. 
• Must be able to work in a Biohazard Environment
• Must be able to lift heavy boxes up to 50 pounds
• Must be able to work an 8 hour day, after-hours and weekends as required

EDUCATION REQUIRED: 
• High School diploma or GED required
• Familiarity with cGMP and Returned Goods
• Previous QA Inspector experience

YEARS OF EXPERIENCE
• 1 – 3 years of medical device manufacturing experience

DESIRED/PREFERRED QUALIFICATIONS
• Previous returned used product experience (Blood borne pathogens, waste disposal, chemicals handling, Hepatitis Vaccination)
• Basic instrumentation and electrical knowledge would be very helpful

ENVIRONMENTAL FACTORS/WORK ENVIRONMENT:
Work is performed inside a professional office environment/office building, with ambient temperature and under florescent lighting, with minimal noise levels. Incumbent routinely uses standard office equipment such as a computer, keyboard, phone, filing cabinets and fax machines.

REF: 162000098
Location: Miami Lakes, Florida