We are seeking an experienced, high caliber Technician II, Quality. This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product manufacturing or system/services support.
This is a 2nd shift opportunity, 3:30 pm to 2 am Monday thru Thursday.
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.
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
* Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
* Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
* Performs other related duties and responsibilities, on occasion, as assigned
* Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.
* Working environment varies from standard office/cubicle with air/sound/light control to general laboratory and production areas with varying physical conditions including “clean room” situations.
* Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.
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
* See Technician Leveling Chart for additional specific criteria
* Ability to work in a highly matrixed and geographically diverse business environment.
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
* Ability to leverage and/or engage others to accomplish projects.
* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
* Multitasks, prioritizes and meets deadlines in timely manner.
* Strong organizational and follow-up skills, as well as attention to detail.
* Ability to maintain regular and predictable attendance
Your preferred qualifications and education:
* 2 year technical degree preferred
* Prior medical device experience preferred
* ASQ CQT certification or equivalent preferred
* Experience working in a broader enterprise/cross-division business unit model preferred.
**Job:** **QL-Quality Assurance*
**Title:** *Quality Technician II*
**Location:** *Minnesota-Plymouth*
**Requisition ID:** *150001OM*
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