We are seeking an experienced, high caliber Technician II, Quality to assist engineers in developing and maintaining quality engineering methodologies and provide quality technical support within new product development, manufacturing, or system/services support.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
This is a 2nd shift opportunity. Hours are 4 pm to 2:30 am M-TH.
Impact this role will have on St. Jude Medical:
* Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements.
* Document nonconformances as appropriate and assist in the resolution of nonconformances
* Monitor and/or perform calibration and maintenance of all test equipment and fixtures
* Initiate related documentation changes
* Perform Process Control & Monitoring of critical-to-quality parameters and specifications
* Collect data, summarize, analyze, perform basic statistical analysis on, and document test results
* Assist with or perform Gage R&R studies
* Assist with the selection, installation and programming of precision measuring equipment
* Assist in designing, building, and evaluation of test methods and inspection fixturing, providing improvement recommendations
* Create and maintain control plans for products and processes
* Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations
Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:
* High School degree required
* 2-4 years experience
* Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning
* Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements
* Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design
* Training in blueprint reading and experience with sampling techniques
* Good communication and computer skills, including data analysis and report writing skills
Your preferred qualifications and education:
* Prior medical device experience preferred
* ASQ CQT certification or equivalent preferred
* 2 year technical degree preferred
**Job:** **QL-Quality Assurance*
**Title:** *Quality Technician II*
**Location:** *Minnesota-Plymouth*
**Requisition ID:** *1600004D*
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