What are the responsibilities and job description for the Quality Assurance Inspector I position at Engineered Medical Systems, LLC?
The Quality Assurance Inspector I will be inspecting product to assure that it meets or exceeds the requirements set forth by customer specifications and quality acceptance criteria.
Description
- Perform first article, in-process, and final product inspection using drawings, specifications, and/or related instructions.
- Read manufacturing prints and determine relevant features for verification of accuracy.
- Understand and complete Document Review Checklist (DRC and Quality Inspection Report (QIR) accurately.
- Capture results data and store electronically in correct file folders.
- Correctly utilize / interpret generalized inspection equipment, to include micrometers, calipers, comparators, and related gages and equipment.
- Check out and return gages for each inspection.
- Maintain strict focus on accuracy, neatness, and thoroughness of product inspection and documentation of results.
- Identify non-conforming product and notify appropriate personnel or management.
- Record production through Job Boss system.
- Performs other job duties as assigned.
- Support of the EMS Quality Policy and Quality Objectives.
This team member supports various activities that contribute to the overall EMS objective of compliance to FDA regulations & ISO 13485 requirements. Ongoing collaboration with additional EMS roles is required.
Requirements
- A minimum of a High School diploma or general education degree (GED) is required.
- General understanding of proper documentation/quality requirements for a regulated environment.
- Good math skills.
- Works well under pressure.
- Ability to think critically and have a strong attention to detail.
- Have an understanding of relevant Safety requirements.
- Must be able to work in a team environment.
- Must be able to speak, read and write in the English language.
Restrictions
- Good vision either natural or thru correction (Glasses/Contacts lens) is needed for this position.
- Levels of Monochromacy, also known as Color Blindness, must be known to establish appropriate risk for certain types of inspection that are dependent on color recognition.
- Able to lift or maneuver tools and material within your scope of responsibility, using or requesting proper and approved maneuvering equipment where necessary.
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The Company considers this Application for Employment to be a part of the personnel record.
THIS COMPANY IS AN AT-WILL EMPLOYER WHERE ALLOWED BY APPLICABLE STATE LAW. THIS MEANS THAT REGARDLESS OF ANY PROVISION IN THIS APPLICATION, IF HIRED, THE COMPANY OR I MAY TERMINATE THE EMPLOYMENT RELATIONSHIP AT ANY TIME, FOR ANY REASON, WITH OR WITHOUT CAUSE OR NOTICE. NOTHING IN THIS APPLICATION OR IN ANY DOCUMENT OR STATEMENT, WRITTEN OR ORAL, SHALL LIMIT THE RIGHT TO TERMINATE EMPLOYMENT AT-WILL. I UNDERSTAND THAT NO COMPANY EMPLOYEE OR REPRESENTATIVE HAS THE AUTHORITY TO ENTER INTO A CONTRACT REGARDING DURATION OF TERMS AND CONDITIONS OF EMPLOYMENT OTHER THAN THE PRESIDENT/CEO OF THE COMPANY AND THEN ONLY BY MEANS OF A WRITTEN CONTRACT SIGNED BY THE PRESIDENT/CEO.
I authorize the Company and/or its agents to confirm all statements contained in this application and/or resume as it relates to the position I am seeking, to the extent permitted by federal, state, or local law. Federal law and some states require a separate disclosure and consent when obtaining background reports from a consumer reporting agency. I understand I will be asked to complete any requisite consent forms for the background check which may be required by federal, state and/or local law. I agree to sign these forms and understand that my offer of employment may be conditional upon the background check.
I AUTHORIZE AND CONSENT TO, WITHOUT RESERVATION, ANY PARTY OR AGENCY CONTACTED BY THIS EMPLOYER (INCLUDING ANY AND ALL PRIOR EMPLOYERS OF MINE) TO FURNISH INFORMATION REGARDING MY PREVIOUS EMPLOYMENT HISTORY AND/OR ANY OF THE ABOVE-MENTIONED INFORMATION. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company pursuant to this authorization from any liability, claims, charges, or causes of action which I may have as a result of the delivery or disclosure of the above requested information. I hereby release from liability the Company for seeking such information and all other persons, corporations, or organizations furnishing such information.
If hired by the Company, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States by this Company as required by the Immigration Reform and Control Act of 1986. I also understand this Company employs only individuals who are legally eligible to work in the United States.
