Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?
We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD):
Summary: Perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices Identify and control non-conforming material.
Duties and Responsibilities
? Perform visual, dimensional and functional inspections of purchased parts, sub assemblies, or finished company products according to defined criteria using standard physical, mechanical and/ or electrical measurements.
?Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices
?Perform First Article Inspection per the request of Quality Engineer for accepting new suppliers or process changes, etc.
?Identify, segregate, and contain nonconforming material including completion of associated paperwork and associated nonconformance database transactions. Familiar with RTV process to return non conforming material to the vendor.
?Develop and document standard operating procedures, inspection and test procedures.
?Work with planning and manufacturing in order to provide support to meet schedules.
?Rework or reject subassemblies or finished products as required.
?Determine inspection quantity based on sampling plan and accurately document the results of the inspections and testing
?Maintain all controlled document files and test records in a timely and accurate manner.
?Coordinate calibration of all test equipment and fixtures
?Monitor critical equipment and instrumentation to ensure proper operation and calibration.
?Assist in the writing and updating inspection procedures, protocol and checklist.
•High school diploma or equivalent required
-Good arithmetic skills are required
-Working knowledge of measurement instruments such as Smart Scope, calipers, Multi-meters, pin gauges, micrometers, etc and automated test systems
-Minimum of 2+ years of Quality Control experience, preferably in the medical device field
-Ability to interpret engineering drawings, product specs, working knowledge of metrology equipment
-Knowledge of FDA quality systems regulations and ISO 13485 desired
-Excellent interpersonal skills, good organizer and self starting, pro-active team player
-Experience in 5S / Lean Manufacturing desired
-Proficient in SAP and EPIQ systems or related experience in other ERP systems
-IPC-A-610 (Certifications desired)
St. Jude Medical - 18 months ago
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