TITLE: Quality Engineer (Senior)
LOCATION: Jacksonville, FL
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting full time, one year contract opportunity for a Quality Engineer with one of our top clients in Jacksonville, FL.
· The Senior Quality Engineer will be responsible for 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.
· The Senior Quality Engineer will 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.
· May supervise the work of QA technicians in a project context.
· BA/BS in Quality Engineering or related discipline.
· 10+ Years experience in Dedical 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
In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect: Competitive pay, paid holidays, yearend bonus program, portable 401(k) plans, recognition and incentive programs, and access to continuing education via the Kelly Learning Center (eLearning)
Kelly Services® is a U.S. based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
About Kelly Services®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project, a free iPad® app by Kelly Services.
Since employing its first engineer in 1965, the Kelly engineering specialty has grown to be recognized as a leading provider of engineering resources to customers in such industries as automotive, chemical, defense, electronics, energy, medical device and pharmaceutical.
Want more information? Visit kellyservices.com/engineering
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