Kelly Services Senior Quality Engineer in Plymouth, Minnesota

Senior Quality Engineer Plymouth, MN

Kelly Services is currently seeking a Senior Quality Engineer for one of our top clients in Plymouth, MN. As a Senior Quality Engineer placed with Kelly Services you will responsible for establishing, implementing and maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Additionally, you will be responsible for leading Material Review Board, Quality Liaison on new product development core teams, and internal/external failure analysis. The SRQE will also assist in issues related to Metrology, Inspection, Testing, and a vendor certification program.

Role and Responsibilities

  • Will lead and manage the Material Board to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.

  • Participates as a key member of new product development core teams, to help ensure that new product quality plans (validation plans, raw/component material specifications, etc.) and risk management files are appropriately established.

  • Designs and develops forms and instructions for recording, evaluating, and reporting quality data.

  • Designs and develops forms and instructions for recording, evaluating, and reporting quality data.

  • Will assist in issues related to Metrology, Inspection, Testing, and Product stability. As assigned, investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.

  • Based on operational/quality requirements, provide test equipment selection and validation.

  • Utilize formal problem solving techniques to resolve product and/or process related issues.

  • As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.

  • Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.

  • Perform Supplier Quality Audits as necessary.

  • Assist with the development and maintenance of the company-wide validation program.

  • Reports verbally and in writing to the Director / Manager regarding the progress and results of projects. Participates with the Director / Manager in the preparation of divisional, departmental, and project goals. Assists the Director / Manager in presentations of technical nature when requested.

  • QE will be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as EN46001/ISO13485/MDD Standards.

EDUCATION and/or EXPERIENCE :

  • BS/BA degree with a scientific emphasis required. ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended. Minimum of eight to ten (8-10 years’ experience in a related regulated medical device environment.

Quality Engineer -

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 2016 was $5.3 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm