Quality Assurance Engineering Supervisor

General Summary

The QA Engineering Supervisor is responsible for supervising and overseeing various areas of the Quality System and the specialists who work in those areas.

Specific Duties and Responsibilities

Coordinate scheduling of QA Engineering Specialists for coverage, prioritization, and workload*

Provide ongoing feedback and mentoring of QA Engineering Specialists – including writing and delivery of annual performance evaluations and professional growth plans*

Coordinate with internal customers to establish prioritizations and work through discrepancies*

Communicate and train internal customers when processes are changed*

Evaluate procedures and work instructions for processing improvements and implement changes as necessary*

Support and defend Quality System processes during internal, notified body, FDA, and State Agencies audits*

Proactively seek system improvements and maintain compliance while continuing to make systems leaner and more intelligent

Communicate Quality System issues to upper management, presenting solutions as appropriate*

Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *

Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *

Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *

Ensure other members of the department follow the QMS, regulations, standards, and procedures. *

Perform other work-related duties as assigned.

*Indicates an essential function of the role

Location: Roseville, CA

Salary: $80,000 to $110,000

Position Qualifications

Minimum education and experience:

Bachelor's degree with 2+ years of experience in Quality Assurance, Quality Control, biotechnology, document control, or a related field, or an equivalent combination of education and experience

Additional qualifications:

Proficiency with MasterControl and Microsoft Professional Office Suit (Word, Excel, Access, PowerPoint)

Thorough knowledge and understanding of FDA’s QSR, ISO standards, and the MDD/MDR

Prior supervisory experience strongly preferred

Solid problem-solving, decision-making, and leadership skills required

Strong oral, written, and interpersonal skills