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10 days old

Sr. Design Quality Engineer

Kelly Services
St Louis, MO 63108
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.
Posted: 2019-08-09 Expires: 2019-09-09

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Sr. Design Quality Engineer

Kelly Services
St Louis, MO 63108

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