CorTech LLC
QA Specialist III
PayRate: $38.99/HR
Shift: 9am-5pm
CorTech is looking to hire a QA Specialist III in Des Plaines, IL.
Job Description:
Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs. Main Responsibilities: Works with a cross functional team to write and execute qualification and validation documents which meet Abbott and regulatory requirements. Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, test method validations in support of a manufacturing expansion. Supports on-market change control projects. •Supports Nonconformance initiation, CAPA investigations. Excellent understanding of Design Control and Change Control.
Minimum Requirements: Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience. At least 5 years work experience in Quality or related field experience; Has a history of completing successful projects and driving positive compliance outcomes. Preferred: •Bachelor’s or master’s degree in one of the following Engineering disciplines: Chemical, Electrical, Bio-medical, or Mechanical •5+ years of relative professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry
•Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 •Strong technical writing skills; Polished verbal and written communication skills