Senior Quality Engineer - Medical Devices QA Lead

Regulatory Jobs; Alameda (CA); Vor Ort; USD 125.000 - 175.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

Life insurance

AD&D

Disability insurance

401(k) with employer match

Parental leave

Paid holidays

Vacation days

Sick time

Zusammenfassung

Penumbra, Inc. in Alameda, CA, is seeking a Senior Quality Engineer to plan, implement, and maintain quality systems for medical devices. You will lead QA activities, ensure regulatory compliance, and support design controls while collaborating with cross-functional teams.

The role requires a strong background in ISO, CAPA, PFMEA, and audits, with experience in medical device manufacturing. This position offers competitive compensation and comprehensive benefits.

Qualifikationen

• Bachelor’s degree in Engineering or Life Science with 5+ years in QA/regulatory environments.
• Advanced degree preferred.
• Experience with PFMEA, NCRs, Failure Investigations, and Change Control.
• Auditing, design review, sterilization, project management and product development desired.
• Experience with contract manufactured medical devices.

Aufgaben

• Lead quality efforts to design, develop, and improve products.
• Coordinate engineering work phases across projects with varied scopes.
• Support FDA inspections, ISO audits, and notified body reviews.
• Develop and maintain QMS procedures and documentation.
• Train staff and manage performance through feedback and development plans.

Kenntnisse

Quality Assurance

Regulatory compliance

Analytical thinking

Project management

Ausbildung

Bachelor’s degree in Engineering/Life Science

Advanced degree preferred

Tools

PFMEA

NCRs/CAPA processes

Auditing/Change Control

Jobbeschreibung

Penumbra, Inc. in Alameda, CA, is seeking a Senior Quality Engineer to plan, implement, and maintain quality systems for medical devices. You will lead QA activities, ensure regulatory compliance, and support design controls while collaborating with cross-functional teams.

The role requires a strong background in ISO, CAPA, PFMEA, and audits, with experience in medical device manufacturing. This position offers competitive compensation and comprehensive benefits.