QA Specialist

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 review qualification and validation documents which meet 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. Especially in HPLC synthesis, purification and testing.
• Supports on-market change control projects.

• 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