Monument, Colorado

Job Title: Validation-Manufacturing Engineer

Kelly Engineering, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Validation/Manufacturing Engineer for a long-term engagement at one of our Global Medical Device manufacturing clients in Monument, CO *. * This role is a full-time, fully benefitted position. As a Kelly Engineering employee, you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You will also receive a generous paid time off allowance, including holiday, vacation, and sick/personal time.

POSITION SUMMARY

As a Quality Engineer, you’ll support the manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with engineering support of production.

KEY JOB RESPONSIBILITIES :

• SUMMARY Represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. · Develop and maintain QA plans and process routings, which reflect intended/actual activities.· Provide support for all quoting activities by participation in initial process design, development, and implementation phases.· Evaluate and support inspection processes via inspection aids and instruction guidelines.· Support all training programs by development and implementation of specialized training sessions for all applicable functions.· Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.· Review all supplier or customer discrepancies. Coordinate and track the corrective/preventative action effort.· Provide trend analysis of defects occurring at the customer, supplier and internally.· Participate in the vendor survey activities as applicable.· Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts.· Interface with all departments as applied to the Policies and Procedures with special regard to ISO and GMP documentation.· Monitor departmental activities and provide technical and logistical guidance/support for the quality engineering staff as applicable.· Interface and provide technical support on quality issues with the customer as needed.· Support and focus corrective action efforts and utilizing the SPC data and corrective action tracking package and create and implement any meetings, procedures, or team-building concepts as necessary as part of the corrective/preventative effort.· Serve as liaison between Jabil Healthcare and suppliers or customers on quality related issues.· Improve technical support for the quality organization.· Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.· Comply and follow all procedures within the company security policy. Experience:

• Test Method Validation

• Gauging techniques and validation (GR&R)

• Gauge design

• Master Validation Plan and supports IQ/OQ/PQ

• Statistical techniques (six sigma) MINIMUM REQUIREMENTS Bachelor's degree required, and 3 years related experience; or equivalent combination of education and experience.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.