Quality Assurance Engineering Supervisor

Penumbrainc; Roseville (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

Life & AD&D insurance

401(k) with employer match

Paid parental leave

11 paid holidays

Vacation accrual with tenure

Paid sick time

Job summary

Penumbra, Inc. in Roseville, CA is seeking a QA Engineering Supervisor to oversee the Quality System and QA Specialists. You will coordinate staffing, mentor staff, and ensure compliance with FDA QSR and ISO standards while driving process improvements.

The role requires a Bachelor's degree with 2+ years in QA/related fields and preferred supervisory experience. Comprehensive benefits and a team focused on groundbreaking therapies are offered.

Qualifications

• 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
• Thorough knowledge of FDA QSR, ISO standards, and MDD/MDR along with quality systems
• Prior supervisory experience strongly preferred
• Strong problem-solving, decision-making, and leadership skills
• Excellent oral, written, and interpersonal communication skills

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 audits (internal, notified body, FDA, state agencies)
• Proactively seek system improvements and maintain compliance while making systems leaner and more intelligent
• Communicate Quality System issues to upper management, presenting solutions as appropriate
• Select, manage, train, and develop staff; set objectives and provide ongoing feedback through reviews
• Adhere to QMS and regulatory standards and procedures
• Understand security, privacy, and compliance principles applicable to the company
• Ensure other department members follow QMS and regulations
• Perform other duties as assigned

Skills

Leadership

Problem-solving

Decision-making

Communication

Education

Bachelor's degree + 2+ years QA/related field

Tools

MasterControl

Microsoft Office

Job description

General Summary

The QAEngineering 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

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).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

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.