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Job Title:     Senior Quality Engineer
Job Location:  FL: Jacksonville
Pay Rate:      35.79
Job Length:    over 1 year (contract)
Start Date:    2012-10-26

Company Name:  Advanced Technology Solutions
Contact:       Autumn Ortenzi
Phone:         732-918-4664
Fax:           732-918-4666

Description:   ATS is an information technologies consulting company providing services to Fortune 500 companies nationwide. ATS specializes in providing full-service staffing solutions by providing technical and business personnel through staff supplementation and project engagements. The company has extensive contacts within its Fortune 500 client base and is able to access a large pool of talented and responsive professionals with proven records of accomplishment in both the technical and business fields.                                       We are currently seeking a Senior Quality Engineer whose essential duties and responsibilities will include the activities of Design Control, Validation, Regulatory Compliance, Qualitative and Quantitative data analysis, Complaint investigation and analysis, Manufacturing Support, Training, Metrology and Gage R&R, and other Quality Functions under the direction of the Process Analytical Technologies Project Manager.                                         Duties and activities include:          - Get involved with leading projects of moderate scope requiring engineering team effort or a multi-discipline team effort              - Assign and assist in providing engineering related duties or projects to lower level engineers, designers and technicians             - Ensure compliance to quality policy, respond to customer complaints, perform audits, develop test methods and write procedures for material characterization          - Maintain and follow proper ISO procedures and GMP requirements                - Provide technical assistance and leadership required to plan and implement projects to develop, install and qualify new tools and processes for manufacturing or for improving existing processes according to business plan objectives               - Provide engineering expertise in the design, fabrication, development, installation, validation and qualification of equipment / product which may include feasibility studies and proper documentation for justification of project and training to ensure proper operation of the equipment                 - Monitor and control programs, identify issues and ensure they are resolved            - Ensure proper documentation is prepared or corrected to reflect any changes that are implemented              - Provide assistance to production as required          - Plan work schedule, expenditure, attend meetings and prepare monthly reports as required              - Ensure effective communication of ideas, information and issues to appropriate stakeholders           - Assign, delegate and assist in the completion of engineering tasks or projects to lower level engineers                                       SUPERVISORY RESPONSIBILITIES            May supervise the work of QA technicians in a project context.                                  Requirements            - BA/BS in Quality Engineering or related discipline.            - 10+ Years experience in medical device industry               - Excellent skills in communication, time management, in-depth analysis, as well as clear, concise business writing             - Strong experience with medical device QSRs in design control and production environments.             - Ability to work with a wide variety of people, including R&D, Manufacturing, and QA, as required to accomplish results with little overall guidance.              - Strong familiarity with Class II or Class III medical devices requirements            - Knowledge of FDA/cGMP and MDD regulations/guidelines.                 - Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis Design FMEA, Process FMEA, Software Development Life Cycle, Statistical Analysis, and Gauge R&R.                                        PREFERRED REQUIREMENT: CQE certification                                        ATS offers health coverage, 401K participation, Long Term Disability and Life Insurance.

Please refer to Job code 12-02270 when responding to this ad.

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