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Sr Supplier Quality Engineer - 55874856 - TT

Job Code: 55874856
Job Location: Goleta, CA
Category: Quality Engineering
Last Updated: 06/29/2017
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Job Description:
• Anticipates team and company need, championing the use of appropriate experimental methodology within the organization and with suppliers. Uses engineering expertise and team input, to lead experimental programs. Develops and conducts experiments, including those of high complexity, 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 documenting results.
• Develops advanced 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.
• Establishes relationship between customer expectation and engineering measurement. As required, uses statistical tolerancing, math modeling, and experimental results to establish specifications. Using a risk-based approach, balances product quality, product specifications, and process capability.
• Works closely with project and program managers to establish product and process testing requirements, using a risk-based approach to balance project timelines, the strength of regulatory submissions, and experimental due diligence. Author’s validation, verification, and inspection assessments to ensure the defensibility of product test data. Serves as a key technical contributor to the plans. Balances testing costs with the statistical strength of the data generated.
• 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.
• Delivers presentations and explains highly complex technical information to others. Facilitates organizational change by negotiating ideas across functional groups.
• Readily identifies safety and quality issues in the immediate work environment and other work areas and recommends and implements solutions for improvement.
• Remains informed about current medical/technical procedures, engineering and material trends by reviewing current literature for technology application, and appropriate coursework.
• Serves as the primary Quality contact for suppliers.
• Performs on-site supplier audits to ensure compliance with Quality Systems procedures, regulations and applicable standards. Ensures supplier audit findings are tracked to timely and adequate closure.
• Works closely with engineering to conduct supplier selection activities to meet supplier development goals. Recommends suppliers based on risk, results and performance.
• Establishes supplier control plans and provides supplier quality input to suppliers such as, but not limited to: statistical process control and capability studies.
• Provides project team leadership and conducts investigations relating to supplier quality issues. Initiates supplier corrective action (SCAPA) and monitors follow-up with assigned supplier base.
• Facilitates resolution of supplier material quality issues.
• Ensures compliance and audit readiness of assigned supplier quality files.
• Maintains and approves Approved Supplier List.
• Routinely reports on supplier performance via routine, defined metrics.
• Performs duties in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: 0%
• B.S. degree in engineering, physics or science
• 4+ years related engineering experience
• 2+ years related engineering experience with an M.S. degree  
• Certified Quality Auditor (CQA) certificate and/or Certified Quality Engineer (CQE) certificate
• Demonstrated engineering field of expertise such as mechanical, electrical, biomaterials, etc.
• Demonstrated ability to effectively manage complex projects
• Demonstrated ability to solve a complex problems in creative and effective ways
• Familiarity with quality improvement tools, including statistical methods
• Demonstrated team advanced leadership skills
• Demonstrated excellent organizational skills
• Demonstrated excellent verbal and written communication skills including ability to effectively develop and resent technical information necessary for the company
• Demonstrated excellent analytical skills
• Demonstrated excellent interpersonal skills
• Medical device industry experience
• Proficiency with personal computer software including word processing, spreadsheet, and statistical programs; computer aided drawing and project scheduling
• Demonstrated advanced understanding and application of Quality System requirements, including FDA GMPs and ISO 13485 and documentation procedures
• Familiarity with biomaterials and their properties
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 55874856TT
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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