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Ley Gorrell
02-17-2004, 01:58 AM
We are currently recruiting for the following positions on the West coast/U.S. in the medical device industry. Client prefers candidates who are already in the western U.S. No sponsorship or visa transfer is available. Please forward resume in Word format to
leygorrell@inreach.com
thanks,
Ley Gorrell ProSource
http://www.leygorrell.com

Senior Quality Assurance Engineer: Provide quality planning and technical support as the Quality core team member on new product development (R&D) project teams. Utilize quality function deployment in translating customer needs into design targets for implantable medical devices. Development, evaluation, procurement and installation of equipment used to measure and evaluate product performance. Use statistical tools to drive test method validations. Support product design verification and validation on new or modified product designs. Write test protocols and reports to support design verification & validation. Lead risk management efforts from product concept to product launch. Conduct thorough hazard analysis. Gain team consensus on inputs to design-FMECA and process-FMECA. Support process validation activities across multiple manufacturing sites. Write test protocols and reports to support process validation. Rationalize and implement statistically sound sampling plans and process control plans. Identify critical inspection characteristics in a manufacturing process. Develop a thorough knowledge of all equipment and facilities used in the stent and catheter manufacturing processes. Communicate within regarding any quality related issues including non-conforming material reports and corrective action reports, to ensure closure of the problem and that remedial and corrective actions are implemented. Lead the failure analysis of returned devices. Develop, implement and improve quality systems to achieve and maintain FDA facility registration, ISO certification and CE marking. Improve upon manufacturing and business processes through use of six-sigma, lean manufacturing, DOE and other tools. Provide quality support to manufacturing floor activities, such as SPC implementation, process analysis, and monitoring of process control measures. Assist in developing qualified suppliers. Provide sampling and technical support to Receiving Inspection, including coordination of first article testing and other testing required for process/equipment validation. Assist in hiring and training for the QA staff. Coach job performance of direct reports and direct personnel actions as required. Document and train the QA Supervisors, Auditors, and technicians to follow the appropriate laboratory product inspection procedures. Provide backup for the QA Manager during his/her absence. Requires extensive experience with: product development, design verification and validation, Test Method development and validation, hazard/risk Analysis, tolerancing and stackup analysis, DOE, statistics, regression, ANOVA, hypothesis testing, confidence/ tolerance limits, SPC, process development and validation, process improvement tools, Lean Manufacturing, Six Sigma, Theory of Constraints. Experience with Pharmacology and with combination drug/medical device products preferred. Conceptual ability to deliver on multiple projects simultaneously. Great ability for reasoning and logical deduction. Ability to shift between tactical and strategic thinking. Ability to shift between abstract and concrete concepts. Interpersonal, excellent prioritization, and verbal/written skills. Highly proficient at influencing peers and senior management. West coast. To $110K.

Clinical Research Associate: With minimal supervision, assist with overall successful conduct of assigned studies and assist in preparation of sections of the Investigational Plan. Assist in site activation (e.g. start-up document preparation, distribution, receipt, and review). Assist in preparation of study training materials and training of investigators, site staff and Client field staff. Set-up and maintain accurate study status and implant logs and assist in coordinating field staff activities with clinical site needs. Assist in follow-up and resolution of site issues noted by field staff and in compilation and review of adverse event information. Assist in compilation, review and conclusion of device complaints and in study closure activities (e.g. close-out document preparation, distribution, receipt and review, audit and archive). Assist data management group with review of clinical data/information and oversight of data correction and in preparation of annual, interim and final reports and presentations. Assist in control of device allocation, distribution and reconciliation and in preparation of study budget and project plans. Assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). May act as Clinical Affairs representative, interfacing with representatives from other key functional groups including Research and Development, Regulatory Affairs, Manufacturing, Sales, Marketing, Legal and European Clinical Groups. May provide work direction to Clinical Research Assistants and monitoring at participating sites to ensure compliance with the Investigational Plan and appropriate regulations, guidelines and policies. Contribute to ongoing SOP development and review. Perform other duties as assigned. Participate in training to enhance knowledge base. May attend relevant scientific/medical meeting. Requires strong written and oral communication skills and proficient knowledge of medical terminology. Working knowledge of GCP and regulatory compliance guidelines for clinical trials. Working knowledge of monitoring functions and working knowledge of clinical research study design. Computer skills (MS Office products, word processing, spreadsheets, etc.). High attention to detail and accuracy and ability to manage multiple tasks. Good prioritization and organizational skills. Excellent problem solving skills. Interpersonal Skills: Positive flexible outlook and dependable.
Good interpersonal communication skills and works effectively on cross-functional teams. Presents professional manner and appearance. Travel requirements up to 30%. Bachelor's degree (technical or non-technical). Technical degree defined as engineering, life sciences or related medical/scientific field. 2-5 years experience directly supporting clinical research or relevant experience in a medical/scientific area. Masters degree will substitute for one year of experience. Ph.D. or MD will substitute for 2 years of experience. West coast. To $85K.

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