General SummaryThe 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 QualificationsMinimum 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
What We Offer• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
