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Quality Med Device Product Engineer

Company: Kelly Services
Location: San Angelo
Posted on: June 13, 2019

Job Description:

Every day, Kelly Services connects professionals with opportunties to advance their careers.

We are currently seeking a Quality Engineer, with Combination Product/Medical Device experience to support Product Life Cycle Management activities and other projects for one of our clients. Our client is very well known as one of the largest, most innovative medical device and solutions, in orthopaedics, spinal care and neuroscience, in the world today.

This opportunity also offers an enhanced benefits package from Kelly Services which includes 401K participation, health insurance, PTO, and paid holidays.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT cannot be considered for this position).


--- Assess the LCM projects and validations; provide risk assessments and remediation plans. Ensure projects remain on track and on schedule.

--- Provide Technical Validation Engineering support to write, obtain approval, execute and close out assigned validation activities as required. Write, review and execute qualification and validation protocols on assigned pieces of equipment, processes and inspection devices.

--- Support validation activities including Installation Qualification, Operational Qualification and Performance Qualification. Process and Equipment validations will include floor layout optimization meeting ergonomic design needs and Lean principles.

--- Write, revise and gain approval for controlled documents such as completion reports, process specs, work instructions, training manuals and Process Failure Mode Effect Analysis.

--- As requested, support Quality System remediation activities.

Required Qualifications:

  • A minimum of a bachelor's degree in Sciences, Business, Engineering or related technical field is required

  • A minimum five (5) years relevant experience in Quality, Manufacturing or Product Development Engineering is required

  • Experience managing multiple projects/requirements in a fast-paced environment is required

  • Experience with Combination Products in the Pharma/Medical Device industry is desirable.

  • Experience working in the medical device/diagnostic/pharmaceutical OR a regulated industry is required

  • Knowledge of FDA's QSR and ISO regulations is preferred

  • Root Cause Analysis experience is preferred

  • Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development is preferred

  • Certification in ASQ Certified Quality Engineer, Lean

    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.


    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 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 Med Device Product Engineer, Engineering , San Angelo, Texas

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