Quality Assurance Engineering Supervisor (Medical Device)

Penumbra, Inc.; Roseville (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

401(k) with employer match

Paid parental leave

Vacation days

Job summary

Penumbra, Inc. in Roseville, California is seeking a QA Engineering Supervisor to oversee the Quality System and mentor QA Engineering Specialists. The successful candidate will support compliance efforts and lead system improvement initiatives.

This role requires a Bachelor's degree and a minimum of 2 years in Quality Assurance, with skills in leadership, problem-solving, and proficiency in relevant tools. A generous benefits package is offered, including medical, dental, and paid leave.

Qualifications

• Minimum 2 years experience in Quality Assurance, Quality Control, or related field.
• Proficiency with MasterControl and Microsoft Office is necessary.
• Thorough knowledge of FDA’s QSR and ISO standards required.

Responsibilities

• Supervise and mentor QA Engineering Specialists.
• Coordinate scheduling and establish work prioritizations.
• Support compliance during audits and propose system improvements.

Skills

Problem-solving

Leadership

Interpersonal skills

Written communication

Oral communication

Education

Bachelor's degree in relevant field

Tools

MasterControl

Microsoft Office Suite

Job description

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

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
• 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).

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.