Quality Assurance Engineering Supervisor

Penumbra • Roseville, CA

19h • Onsite

About The Position

The QA Engineering Supervisor is responsible for supervising and overseeing various areas of the Quality System and the specialists who work in those areas. This role involves coordinating scheduling, providing feedback and mentoring, communicating with internal customers, evaluating procedures, supporting audits, and driving system improvements. The supervisor will also manage, train, and develop staff, ensuring adherence to the Company’s Quality Management System (QMS) and relevant regulations. This is a key role in maintaining compliance and enhancing the efficiency of quality systems.

Requirements

• 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.
• 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.
• Solid problem-solving, decision-making, and leadership skills required.
• Strong oral, written, and interpersonal skills.

Nice To Haves

• Prior supervisory experience strongly preferred.

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.

Benefits

• 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
• paid sick time in compliance with applicable law(s)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager