Title: Quality Operations Manager

Location: South San Francisco

Type: 100% onsite

Salary: Commensurate with experience

Type: Full time permanent

The Quality Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of molecular diagnostic products for commercial or clinical distribution

Responsibilities

- Responsible for incoming and Final Product QA, as well as quality process in support of manufacturing.

- Interfaces with local Operations, Quality Management, and Development to assure all products and processes are in accordance with company standards and quality systems

- Performs hands-on activities including Nonconformance review and approval, Validation protocol and report review and approval, documentation change workflows, Planned Deviation review and approval

Assures local organizations are trained on QMS policies and procedures, as well as QSR and ISO requirements through the development and implementation of compliance education and training

Qualifications:

• Bachelor's degree in Clinical/Biological Science or related field
• 3+ years in the IVD, device, or pharmaceutical industry dealing with quality management
• 3+ years of quality team management experience
• Experience with QSR/ISO audit process and conducting audits