Quality Assurance Engineer

The Quality Assurance Engineer coordinates deviations and material review board (MRB) processes, performs and supports internal audits, supports 3 rd party audits and regulatory inspections, supports validation of critical equipment, systems, and processes, and supports maintenance of Quality Systems documentation.



Specific Responsibilities

• Coordinate routing and approval of deviations, material review board (MRB) investigations, and Quality Events through applicable eQMS (Master Control or Trackwise).
• Track deviations and MRBs and lead cross department meetings on deviation status and MRB status.
• Track corrective and preventive actions (CAPAs) issued through eQMS (Master Control or Trackwise) and verify effectiveness according to applicable SOPs.
• Perform and/or participate in assigned internal audits, assign and track associated action items, and generate audit reports.
• Support document retrieval and review for 3 rd party audits and regulatory inspections.
• Develop and execute assigned cleaning validation and equipment qualification protocols.
• Review and revise Quality Systems documentation as assigned.

• Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.
• Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work.
• Performs such individual assignments as management may direct.
• Other duties as assigned.

• Four-year degree from an accredited university (preferred), > 3 years' experience in a technical Quality role, or equivalent combination of education and experience
• Prior experience in an FDA regulated industry in a quality, regulatory, or technical role.

• General understanding of deviation/nonconformance, CAPA, audits, change control, qualification, and validation.
• General understanding of cGMP and applicable regulations.
• Excellent written and verbal communication skills and ability to communicate with all levels of the organization.