Description
Sr. Quality Engineer (Manufacturing)Position Description
Incumbent provides engineering guidance for new product development, design change projects, and sustaining engineering. Incumbent provides project team leadership for new product development and design change projects which generally include verifications, validations, process optimizations, or test method development. Given broad parameters, incumbent sets up experimental strategies to accomplish project goals with guidance from senior engineering. Authors quality plans. Contributes statistical and experimental knowledge to project teams. Contributes key knowledge of GMPs and other regulatory requirements to project teams, revising company SOPs as required. Assesses and qualifies vendors, solving problem as they arise. Ensures that inspection strategies are appropriate. Ensures all activities are in compliance with Quality System requirements.
Position Responsibilities
1) Under limited guidance, uses engineering expertise and team input, to develop and conduct experiments of moderate complexity in order to solve process and product problems. This includes developing responses, identifying and testing factors, performing protocol development, conducting or supervising tests, reducing data, performing statistical analysis, drawing conclusions, and writing results. For complex data acquisition and data reduction, sets up complex worksheets (macro or formula based) and may write the required software.
2) Develops test strategies and inspections. Designs and conducts experiments to establish the relevancy of test methods. Establishes and/or improves the relationship between product/component requirements and test output.
3) Reviews protocols and reports; shapes experimental strategies as required.
4) Establishes specifications. Establishes relationship between customer expectation and engineering measurement using experimentation. As required, uses statistical tolerancing, math modeling, and experimental results to establish specifications. Balances product quality, product specifications, and process capability.
5) Authors validation, verification, and inspection assessments to ensure the defensibility of product test data. Serves as a technical contributor to the plans. Balances testing costs with the statistical strength of the data generated.
6) Provides quality system guidance and training to ensure compliance to SOPs and appropriate external regulatory standards to other engineering groups and project teams. Initiates changes to SOPs to improve compliance, streamline operations, or save cost. Conducts presentations and explains technical information to others. With limited coaching from management, facilitates organizational change by negotiating ideas across functional groups.
7) Readily identifies safety issues in the immediate work environment and other work areas and recommends and implements solutions for improvement.
8) Remains informed about current medical/technical procedures, engineering and material trends by reviewing current literature for technology application, and appropriate coursework.
9) Other non-routine duties as assigned by Supervisor.
Basic Qualifications
- M.S. degree in engineering, physics or science and 4+ years related engineering experience in manufacturing environment OR
- B.S. degree in engineering, physics or science and 6+ years related engineering experience in manufacturing environment
- Demonstrated engineering field of expertise such as mechanical, electrical, biomaterials, etc
- Demonstrated advanced understanding and application of Quality System requirements, including FDA GMPs, and ISO 9000 and documentation procedures; ability to learn MPSM systems quickly
Desired/Preferred Qualifications
Medical device industry preferred
- Demonstrated ability to effectively manage complex projects
- Demonstrated ability to solve complex problems in creative and effective ways
- Demonstrated advanced team leadership skills
- Demonstrated excellent interpersonal skills
- Demonstrated excellent organizational skills
- Demonstrated excellent verbal and written communication skills including ability to effectively develop and present complex technical information necessary for the company
- Demonstrated excellent analytical skills
- Familiarity with personal computer software including word processing, spreadsheet, and statistical programs; computer aided drawing and project scheduling software preferred
To find out more about Real please visit www.realstaffing.com