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Quality Engineer III - Medical Device Manufacturing

Company: Kelly Services
Location: San Angelo
Posted on: May 10, 2019

Job Description:

Kelly Services-- has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Sr. Quality Engineer - Medical Device at a prestigious Fortune 500-- company working in San Angelo, TX.

This is a 10-month temporary position at 40 hours per week.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "submit now" button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (keig126@kellyservices.com) however your resume must be received via the "submit now" button included within.

Job Description:



  • The Staff Quality Engineer will help to lead project teams and provide major input in the development and manufacture of new products as well the maintenance of current products, materials and processes.

  • This individual will function as a quality representative on multi-functional product development teams in matters relating to Quality Engineering.

  • Will support design control and process validation activities for new and change product efforts.

  • This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.

  • This individual will lead and ensure the development of comprehensive risk management plans and operating procedures for the product and process.

  • The Quality Engineer will ensure effective and comprehensive quality strategies.

  • Will assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action.

  • This individual will ensure the development and validation of appropriate test methods for design and manufacture of products and components.

  • The Quality Engineer will track/trend quality issues over time and generate reports to management and across sites.

  • This Quality Engineer will lead project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations. Will assess, implement and monitor process capability for continuous improvement.

  • This Quality Engineer may be responsible for leading cross-functional work teams and/or managing QA technicians to include direct daily supervision, performance appraisal, behavioral discipline, professional development and on the job training.

  • The Staff Quality Engineer will serve as subject matter expert for key technologies and quality systems.

    Other Responsibilities:

    Provide technical expertise to ensure conformance to ISO, FDA Food Drug Administration MDD Medical Devices Directive based quality systems. Provide support to process excellence initiatives including Six-sigma lean thinking. Direct development consistent application of quality policies procedures in product design development, secondary development transfer operations. Comply with all applicable quality management system, environmental, safety and occupational health policies. for example, ISO 13485, ISO14001 OSHAS18001.

    EDUCATION and/or EXPERIENCE:

    A minimum of a Bachelor s degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is an asset. A minimum of 8 years Quality Engineering work experience is preferred, with experience in the medical device, pharmaceutical or other highly regulated industry also preferred.

    Skills:

    Knowledge of ISO and/or cGMP regulations is preferred. New product development experience is preferred. Supplier Quality Engineering experience is an asset. Sterilization process experience is an asset. General knowledge in Quality Systems Regulations QSR is an asset. An ASQ certification CQE, CQM, CRE or CQA is an asset. Six Sigma Green Belt, Black Belt, etc. or Process Excellence certification is an asset. Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred. Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R D, Operations, Purchasing, Marketing and Medical Affairs. Good communication and presentation skills will be needed. Maturity and ability to display a high level of professionalism is required.

    Physical Demands:

    This position may require up to 10% travel. The ability to work some nights/ weekends/ holidays.
    Why Kelly--?

    Kelly puts you in charge of your career, with access to cutting edge projects and technologies in

    industry leading organizations. Top companies throughout the world have trusted Kelly as a premier

    source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm

    with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety

    and flexibility of working on short term project engagements, or prefer contract-to-hire or direct

    hire placement with our clients, apply with Kelly to explore opportunities that suit your specific

    professional interests.

    About

    Kelly Services--

    As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

    Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

    committed to employing a diverse workforce. Equal Employment Opportunity

    is The Law.

Keywords: Kelly Services, San Angelo , Quality Engineer III - Medical Device Manufacturing, Healthcare , San Angelo, Texas

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