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Click here or scroll down to respond to this candidateJames Jensen: PHONE NUMBER AVAILABLE, EMAIL AVAILABLEBloomington, Minn Street Address
Highly experienced and skilled Quality Assurance professional with proven track record and progressive hands-on experience in Medical Device, Manufacturing, Industrial & Aerospace industries, Operations, and Supply Chain Managements, Materials (Castings Aluminum, Titanium, Stainless, Carbon, Brass, Harpo) Vast knowledge & diverse experiences in Inspection, Calibration, Welding, Painting, Material Planning and Doc control. FDA Quality System regulations and application of Good Manufacturing Practices. Excellent understanding of variations introduced by measurement devices, effective usage of data analysis tools, High-Impact Communication, Courageous Decision Making. Exceptional ability to interact effectively with leadership, additional departments/suppliers. Possess excellent problem solving, organizational, Interpersonal, and outstanding communication skills both written and verbal. Keen attention to detail; critical logical thinking Outstanding ability to make sound judgement and decision making based on evaluations and assessments. Provide effective team leadership and project management for quality investigations and improvements (CAPA, CAR) Per AS9100D, ISO9000 and ISO13485:2003 Professional Experience Engineer,Professional ExperienceQuality Manager Electric Wire Products Corp- St Louis Park, Minn 55426. 6/2024-PresentDeveloping and maintaining EWPs quality management system in accordance with current ISO Standards Organizing and Participation in management reviews.Participation in and making decisions regarding planning and continual improvement of QMS.Oversee Quality staff and coordinate resolution of quality issues. This includes non-conformances and returns of customers.Act as management representative for the quality management systemCommunicate quality issues to management and staff on a timely basisMaintain required records and produce reports per quality system proceduresAuthorize and issue Returned Goods authorization (RGAs)Authorize product/process changes via Engineering Change Requests, or Customer Engineering Change RequestsHaving 17 direct reports in QualityQuality Engineer CPP-Bloomington, Minn 6/2023-6/2024 Create quality plans for product qualification (PPAP and FMEA) as well as validate production processes NPI (New product introduction) quality planning (Work Instructions and Procedure development) Review and implement specifications as directed by customers and the government Review and approve incoming and outgoing purchase orders casting Materials. Aluminum, Titanium. Initiate, monitor, and control internal and external customer requests for corrective action Facilitate and host customer audits when required Authorize product/process changes via Engineering Change Requests, or Customer Engineering Change Requests Act as our customers' release agent upon acquiring relevant certifications. Such as Material certs Authorize and issue Returned Goods Authorization (RGA's)Supplier Quality Engineer Loram - Hamel, MN 6/2020-12/2022 Responsible to drive exception product quality for customer value beyond expectation while ensuring regulatory assurance and optimized cost quality. Support ISO 9000 Quality Process Requirements. Support implementation of initiatives related to supplier processes and improvements. Ensure Corrective and Preventive Action plans are developed and executed at assigned suppliers. Perform supplier quality audits as required by the verification plan or by the Quality Manager. Identify non-conforming materials and workmanship, perform root cause analysis, and implement effective short and long-term corrective actions. Work directly with vendors under the control of the Companys Quality/Logistics. This involves travel to supplier sites so this person must be available to travel at short notice. Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the costs of quality, specifically Incoming rejects, failures, and factory defects.SR Quality Engineer (Contract) TE Connectivity - Andover, MN 3/2020 5/2020 Covid Responsible for controlling the quality of the products for the specified business unit through both proactive and reactive strategies. Review new products in collaboration with engineers, planners, and production along with resolving technical quality problems. Manage new product development activities related to supplier requirements including but not limited to: New Supplier Evaluations, FMEA and Control Plan development and Production Part approval. Execute ongoing supplier audits and continuous improvements. Provide effective team leadership and project management for quality investigations and improvements (CAPA, CAR) AS9100D, ISO9001 and ISO13485:2003Quality Manager Superior Aerospace Precision Machining-Fridley, MN 7/2019 2/2020 Lead employees in the inspection department over 2 buildings. Provide effective team leadership and project management for quality investigations and improvements (CAPA, CAR).AS9100D, ISO9001 and ISO13485:2003 Manage new product development activities related to supplier requirements including but not limited to: New Supplier Evaluations, FMEA and Control Plan development and Production Part approval. Execute ongoing supplier audits and continuous improvements. Conduct audits, including closing out audit findings, create audit-finding reports and determine proper corrective and preventative actions. Documented daily, weekly, and monthly movement of product in and out of repairs.Quality Engineer Modern Tool- Coon Rapids, MN 7/2016 7/2019 Responsible for controlling the quality of the products for the specified business unit through both proactive and reactive strategies. Review new products in collaboration with engineers, planners, and production along with resolving technical quality problems. Manage new product development activities related to supplier requirements including but not limited to: New Supplier Evaluations, FMEA and Control Plan development and Production Part approval. Execute ongoing supplier audits and continuous improvements. Provide effective team leadership and project management for quality investigations and improvements (CAPA, CAR). ISO9001Quality Engineering Technician RMS Surgical Anoka, MN 1/2014 7/2016 Work with engineering and manufacturing to implement effective inspection and control plans for new product development. Act as the quality interface for production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis. Conduct audits, including closing out audit findings, create audit-finding reports and determine proper corrective and preventative actions. Support Quality Technicians to ensure that inspection plans comply with the relevant requirements of customers product requirements. Per ISO9001 and ISO13485:2003Quality Assurance Representative Remmele Engineering Big Lake, MN 06/2012 12/2014 Performed and recorded receiving inspection of purchased products. Per ISO9001 and ISO13485:2003 Performed internal inspections of machined medical instruments by using hand tools and CMMs. Zeiss with calypso software, Minne Tab and QCcalc. Assembled technical conformance documentation such as REVs, EDNs and CANs. Determined inspection scope and acceptance criteria by using QCPs, STMs along with writing NCRs and conducting weekly MRBs.Repair Operation/FIW Inspection Supervisor Olympus America - Maple Grove, MN 03/2007 06/2012 Led a team 12 employees in the repairs/shipping/receiving/inspection departments. Provided technical support and service on Gyrus ACMI products repairs in Maple Grove. Sought out areas of continuous improvement and made recommendations using Lean. Created work procedures and work instructions for repairs. Per ISO9001 and ISO13485:2003 Documented daily, weekly, and monthly movement of product in and out of repairs.Quality Engineer Inspector Gyrus ACMI Inc/Olympus - Maple Grove, MN 2006-2007 Performed and recorded receiving inspection of purchased products. Assembled technical conformance documentation such as REVs, EDNs, and ACNs. Determined Inspection scope and acceptance criteria. By using QCPs STMs. Writing NCMR and conducting weekly MRBs. Responsible for writing inspection procedures.Cummins Power Generation/Onan. - IMF Material Planner - Fridley, MN 2002-2006 Plan the flow of Material through. Misc Sheet Metal, Punch Press, Sheet Metal Assy, Machining, Welding and E-Coat. To the production lines by Setting up Jobs and Releasing according to MRP (Oracle). Controlling Inventory levels of Over 10,000 P/N and Piece parts. Manage material shortages and stock room Transfers. Maintain JSOX requirements for inventory. Help to orchestrate yearly physical inventory.Cummins Power Generation/Onan-IMF Material Coordinator 2002-2006 Plan the flow of internal materials to the production lines in a timely manner. Manage inventory of electronics room. Investigate material negatives and Correct inventory as necessary. Set up Jobs and Release according to MRPCummins Power Generation/Onan-Quality Assurance Technician III 2001-2002 Provide metrology lab support for Machine shop, fabrication and in process Inspections on the shop floor. Run CMMs (USOFT) and do simple calibrations. Inspect first articles for acceptance.Caterpillar Paving Products - Brooklyn Park, MN 1994-2001 Mechanical & Receiving Inspector Performed and recorded receiving inspection of purchased products. Assembled technical conformance documentation such as REVs, EDNs, and ACNs Determined Inspection scope and acceptance criteria. Performed off-site source inspections at vendor locations. Inspector In-process/Final Liaison between Caterpillar and Government Quality Assurance Representative. Reviewed and processed Government contracts for compliance, final acceptance, and sign-off, ensuring compliance with military specifications. Calibration Technician Managed Progage database of 2000+ calibrated instruments. Performed in-house calibrations; scheduled outside calibrations. Ordered tools or supplies for Engineers, Mechanical Engineers, and Fabrication. Fabrication/ Prototype Welder Assisted Engineering with Fabrication prototype projects, including Components of road machinery and special repair work. (Mig, Tig, Stick and Sub arc Welding).Education Knowledge, Skills and Abilities Vocational-Technical course work including certificates for GDT, Practical Gauging and Inspection, Welding (Stick, Tig, Mig and Sub arc welding) ASME,AWS Licensed Fire Fighter Certified First Responder State of Minnesota,Fire Science Internal training on Oracle (GIEA) APICSS, Basics of Supply Chain Management Supervision I, II,III from Employers Association Principles of Process Improvement 5s Workshop Organization Certificate for Zeiss CMMs with Calypso software Certificate of training for ISO 13485:2003, ISO 9001, AS9001D, AS/RM13000 8D Problem Solving Solid works Inspection, Solid Works Essentials, Solid Works Drawings |
