Quality Engineer Lead (Validation)
Company: Sterling Engineering, Inc.
Location: Buffalo Grove
Posted on: November 25, 2022
The Quality Engineering Lead is a " hands-on" position responsible
for planning, coordinating, and managing through completion,
assigned projects to ensure the development and production of
products meet customer and internal quality deliverables.
- Responsible for qualification of mold, and processes from a
quality and compliance standpoint
- Create qualification plans for new assets
- Oversee project deliverables
- Create Validation Protocols and Reports, Product
Specifications, and Change Control activities
- Coordinate and manage the execution of validation protocols and
change control requests.
- Assess results of Customer Complaint investigations and
Corrective Actions for application, validity, and conformance to
FDA regulatory, QSR, ISO, and Customer requirements.
- Bachelor' s degree in Engineering, Science, or a related
- 5 or more years of experience in a Quality position within the
Medical Device industry is required.
- Technical writing experience preferred
- Experience in the Medical Device industry preferred.
- Clean room environment experience
Qualified applicants will receive consideration for employment
without regard to race, color, age, religion, sex, sexual
orientation, gender identity, national origin, disability,
protected veteran status, or genetic information.
Keywords: Sterling Engineering, Inc., Buffalo Grove , Quality Engineer Lead (Validation), Engineering , Buffalo Grove, Illinois
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