Quality Assurance Engineering Supervisor

Penumbra · Roseville, CA

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

 

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