Senior Quality Assurance Specialist

Job Summary:

The Sr. Quality Assurance Specialist assists with the daily operations of the Quality Assurance department. Primary job duties will include document control activities, routing/processing/implementation of ECOs, filing responsibilities of controlled documents for Quality, and facilitating QA training. This position will work closely with multiple functional areas including R&D, Operations, Training, and Marketing.

This position will be the primary person responsible for supporting the ECO and Document Control system with various activities and projects to meet the company’s objectives and key initiatives.

Location: Hybrid in Sunnyvale, CA. (Mon.-Wed. in office, Thursday and Friday remote)

Responsibilities:

• Document Control including releasing approved documents and controlling revisions
• Routing ECOs and associated documents to the appropriate reviewers/approvers
• Assisting other professionals with ECO creation
• Deliver initial training assignments for new employees and assign on-going QA training
• Assigning training to affected employees
• Operate the ECO system within our electronic Quality Management System (eQMS)
• Tracking completion of required training activities within the eQMS
• Assuring completion of all implementation activities

Required Qualifications:

• 2-year associate degree required; bachelor’s degree preferred.
• High proficiency in MS Office suite and Adobe Acrobat
• Candidate must be physically able to sit/stand for long periods of time to complete tasks; use various office equipment (scanner, printer, computer)
• Experience operating a change control system in a regulated environment (medical device, pharma, diagnostics) with five years of experience preferred

Additional Qualifications:

• High proficiency in MS Office suite and Adobe Acrobat
• - Quality Focused
• Strong verbal and written communication skills and interpersonal skills
• Experience with eQMS preferred
• Comprehensive understanding of office equipment including scanners and printers.
• Capacity to work in a high paced, changing environment, and interface effectively with others.