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US: Supplier Quality Engineer in Biotech

Date: 28-May-2015
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Supplier Quality Engineer

ESSENTIAL DUTIES:

Assists team members engaged in establishing and executing inspection methods and acceptance criteria for receiving Raw Materials, Components, Finished product and services (processes) acceptance activities. Assists in establish training plans across the Supply Chain to ensure consistency of inspections. Provides detailed training and is an expert on all the inspection criteria. Resolves conflicts with surrounding product quality, inspection criteria, and inspection. Evaluates and approves Supplier Corrective Actions and follow ups on resolution. Review & inspect facilities and product at key suppliers to ensure compliance with Biomet3i standards Reviews existing and proposed changes to Control Plans for inspection methods and sampling adequacy (Frequency and Size) to assure adequate consumer protection. Establish goals and metrics to drive continuous improvement in product quality, efficiency, safety, training and customer satisfaction. Consults with inspection and production personnel in appropriate application and continuous improvement of inspection, measuring and test equipment. Coach and assists in the development of quality technicians to insure meaningful personal growth and development to ensure expectations and company goals are met. Participate as needed in FDA and Third Party audits. Participates in the Receiving Inspection Material Review Board (MRB) activity and provides analysis of same for Management. Reviews non-conforming material reports (NMRs) for trends and coordinates supplier corrective measures. Interfaces with Purchasing, Research and Development, Manufacturing, Quality Assurance, and/or Suppliers to coordinate and resolve quality-related problems. Initiates corrective and preventive actions, approves corrective action plans, and monitors the effective resolution for these corrective actions. Reviews suppliers manufacturing process validations. Schedules, conducts, and reports results from Supplier Audits to assure that new and existing suppliers meet applicable requirements derived from regulations, external standards and 3i specifications. Coordinates with Purchasing, Research and Development, Quality Assurance Engineering and Manufacturing, to assure that potential new suppliers and/or new parts to be procured from existing suppliers achieve agreed upon quality levels within a compliant regulatory framework. Working with Purchasing, targets suppliers for certification, including process validation requirements, defines criteria to be met, and partners with suppliers to achieve certification status. Interprets results, qualitative and quantitative, as related to quality system compliance and process capability. Lead and/or participates in process improvement initiatives, including but not limited to six sigma activities necessary to achieve objectives. Provides status reports describing progress and concerns related to the above activities. Performs related duties as required.

JOB SPECIFICATIONS:

Bachelorís degree in Engineering required with two to four years of med device experience preferred. Statistical software experience required, Minitab preferred. Outstanding written and verbal skills

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BioTech FYI Center
http://biotech.fyicenter.com/