Thursday, February 9, 2012

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Michelle Davidson posted a job:

"Now Hiring: Proud to be a Quality Engineer? in Franklin, IN Elwood Professional is the division of Elwood Staffing dedicated to the recruitment and placement of highly-trained and highly-skilled engineering, information technology, and management professionals. The Elwood Professional team focuses on matching candidates to clients’ needs for contract, contract-to-direct, and direct hire placements across all sectors and in all industries. Elwood Professional has a network of regional offices with national placement capabilities. COMPANY PROFILE: Leading global consumer packaging company Leading global beverage can maker and rigid plastic packaging Global annual sales of $6.6 billion Employs over 19,000 in 25 countries 70 manufacturing facilities in 25 countries in Europe, North America, South America, and Asia-Pacific rim For the beverage market, manufactures 60 billion beverage cans each year Leading supplier of advanced packaging solutions with unsurpassed global capabilities that attract the world's most innovative, demanding and respected beauty, personal care and home product manufacturers Produce injection molded components for personal care and household goods Healthcare market, production of a broad range of products including plastic containers and closures, drug delivery and medical devices, pharmaceutical pumps and valves as well as ophthalmic packaging. Food market production of high barrier plastic tubs and trays THE ROLE YOU WILL PLAY: Primary quality signatory responsible for providing leadership, guidance and oversight of commissioning, qualifications and validations related to molding, equipment, and software at the Franklin facility. Writes validation documents (e.g. URS, FAT, IQ, OQ, PQ), executes protocols, analyzes and writes summary reports, deviation resolution and CAPA’s. Assists in the implementation of company policies and procedures to ensure compliance to applicable federal, state, and local laws regulating the medical device industry. Manages continuous improvement activities regarding quality of all products, as determined by manufacturing production events, heldware, scrap and customer complaints. Supports customer needs in coordination with plant management. Possesses and maintains an ongoing thorough knowledge of cGMP requirements and regulatory expectations. Responsible for Qualification of Change (Change Control). Reviews and approves manufacturing processes, equipment, and software changes to ensure that quality requirements are met. Assists with Internal Audits and Supplier Quality Audits as needed. Adheres to plant and corporate safety policies. May assist in other areas or perform other duties as required by fluctuating business needs. BACKGROUND PROFILE: Possesses 5-10 years experience in a medical device or other FDA regulated industry preferred. Bachelors Degree in an Engineering discipline preferred. CQE preferred. Must possess a working knowledge regarding ISO quality standards, statistical process control and other quality measurement systems. Experienced in statistically-based Quality Engineering approaches in project and test planning and in the analysis and interpretation of test results (e.g. FMEA, DOE, SPC, Capability Studies, etc.). Working knowledge of standard quality system requirements (ISO 9001, ISO 13485). http://bull.hn/l/F19O/4"

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