Sr Quality Engineer

Penumbrainc; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid parental leave

Eleven paid company holidays

Vacation accrual

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Senior Quality Engineer to lead quality assurance activities across design, development, and manufacturing, ensuring compliance with FDA regulations and industry standards.

You will develop quality plans, conduct risk analysis, manage NCR/CAPA processes, and support inspections, with a focus on continuous improvement and effective collaboration with cross‑functional teams.

Qualifications

• Bachelor’s degree in Engineering, Life Science or related field required.
• 5+ years of QA experience in medical device or regulated industry environment.
• Experience with PFMEA, NCRs, Failure Investigations, and Change Control.
• Auditing, design review, sterilization, project management or product development experience desired.

Responsibilities

• Lead and participate in development and qualification activities for new and existing products.
• Coordinate quality efforts across design, development, and manufacturing.
• Perform design control and quality assurance activities.
• Analyze reports and returned products to recommend corrective and preventive actions.
• Participate in NCR/CAPA boards and assist in QA training.
• Support FDA inspections and notified body audits.

Skills

Quality Assurance

PFMEA

Change Control

NCR / CAPA

Project leadership

Education

Bachelor’s degree in Engineering, Life Science or related field

Job description

General Summary

The Senior Quality Engineer role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for manufacturing. Monitor design control and provide quality assurance support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.

Specific Duties and Responsibilities

• Participate in the development and qualification activities for new and existing products.*
• Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes.*
• Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements.*
• Perform engineering work including one or more of the following:
  • Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
  • Develop and validate measurement methods
  • Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards
  • Support developmental projects in the area of quality assurance
  • Analyze reports and returned products and recommend corrective and preventive action
  • Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
  • Participate in NCR or CAPA board as necessary
  • Assist in and perform QSR training.*
• Support activities during FDA inspections, FDB inspections, and notified body audits.*
• Participate in the development of standard operating procedures.*
• Prepare documentation for inspection/testing procedures.*
• Perform responsibilities required by the Quality System and other duties as assigned.
• 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

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience, preferably in a medical device or regulated industry environment

Additional qualifications:

• Advanced degree preferred
• Experience with Process Failure Mode and Effects Analysis (PFMEA), sustaining projects, commercial medical device manufacturing, Non-Conformance Reports (NCRs), Failure Investigations, and Change Control
• Experience in auditing, design review, sterilization, project management, and/or product development highly desired
• Experience with Contract Manufactured Medical device products

Working Conditions

• General office, laboratory, and cleanroom environments.
• Business travel from 0% - 10%.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Location and Pay

• Alameda, CA
• $125,000 to $175,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

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.

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.