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Quality Engineer - Project and Validation Support at Nemera

Posted in Architecture 9 days ago.

Type: Full-Time
Location: Buffalo Grove, Illinois





Job Description:

We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.


We are adding a Quality Engineer to our team! In this role, the Quality Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products that meets customer and internal quality deliverables. Core responsibilities of this role focus on supporting pharmaceutical and biotechnology clients with projects in varying developmental and FDA approval stages, by assisting with documentation and project work. The Quality Engineer will coordinate and manage the execution of IQ/OQ/PQ validations, create written protocols, and act as a liaison between Nemera and customers for quality related activities.


 


If you’re:



  • Passionate about growing a business

  • Enjoy working as a team

  • Proud to make products that improve patients’ lives

  • And go the extra mile to deliver on your commitments

Then you’ll be successful here!
 


You’ll help us achieve our corporate growth goals by bringing these skills to us:



  • Ability to executes duties in a fast-paced manufacturing environment, both independently and in conjunction with cross functional and global teams.

  • High School Diploma or GED equivalent required. Bachelor’s degree in Engineering, Science or related field strongly desired.

  • 3 or more years of experience in a Quality position preferred

  • Experience in the Medical Device industry required

  • Excellent communication skills with the ability to understand, read, write and speak English required

  • Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.

  • Six-sigma experience, training or certification preferred

  • Intermediate level computer skills, including Microsoft Office, applications required

  • SAP and Minitab experience preferred

  • Ability to work independently from verbal and/or written instructions required

  • Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives

 


Work Environment



  • Works in a clean, fast-paced manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.

  • Ability to regularly lift up to 30 lbs with repetitive movements.

  • Ability to push and pull items.

  • Ability to stand, sit, walk up to 80% of a shift.

  • Ability to travel between office and production departments as well as company buildings required.

  • Up to 25% travel required (some international).