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Kelly Services Sr. Design Quality Engineer in Saint Louis, Missouri

Kelly Services is currently seeking a Sr. Design Quality Engineer for one of our top clients in St. Louis, MO.

OBJECTIVES/ PURPOSE OF JOB

  • Responsible to assure Quality and Compliance, and provide overall Quality guidance during product design and development, design verification and validation, and design transfer to manufacturing.

KEY ACTIVITIES/ RESPONSIBILITIES

  • Represent Design Quality on multi-disciplinary new product development and MOB teams.

  • Ensure project plans adequately address design, validation and Quality departmental requirements and standards.

  • Work with functional departments to ensure tasks are executed compliantly.

  • Management and documentation of Design Control activities through post launch review approximately 1-year post launch.

  • Documentation of Risk Management requirements per ISO 14971.

  • Review/approve GMP documents e.g. production records, analytical method validation, engineering/validation protocols/reports, specification updates DCO s, QCR s.

  • Facilitate GMP production readiness and launch activities, including technology transfer and validation.

  • Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.

  • Support post launch design changes and product updates as required.

SCOPE OF POSITION

  • Provide support for Surgical development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility.

  • Additionally, the role will support marketed product changes and updates MOB.

  • The role includes working with multidisciplinary teams to insure medical device development activities are planned and executed in compliance with Design Control Requirements and procedures.

  • Provide Quality Assurance support to sites as needed.

  • Work with Project Management to lead design teams through lean development methodologies to develop highly capable products.

  • Drive test strategies meeting right first-time expectations

QUALIFICATIONS/ TRAINING Required Education:

  • Bachelor s Degree BS in engineering or scientific discipline Chemistry, Biology, Microbiology.

Skills/Qualifications:

  • Thorough understanding of Design Controls requirements for medical devices, as well as best practices that foster high quality design.

  • Deep knowledge of Design History Files.

  • Excellent analytical, problem solving, organizational, and communication skills

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States.

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.

AboutKelly 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.

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