Senior Quality Engineer, Electronics – Medical Devices

Penumbra, Inc.; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match

Paid parental leave

Generous vacation policy

Job summary

A global healthcare company is seeking a Senior Quality Engineer to oversee QA processes for innovative medical devices. The ideal candidate will have at least 5 years of experience in quality assurance and a bachelor's degree in engineering. Responsibilities include leading quality efforts, developing standards, and supporting FDA inspections. The role offers a competitive salary and a comprehensive benefits package.

Qualifications

• 5+ years of experience in Quality Assurance in regulated industry.
• Experience with Non-Conformance Reports (NCRs) and Change Control.
• Familiarity with auditing and design review processes.

Responsibilities

• Lead quality efforts to design and improve products.
• Develop quality standards and monitor design control.
• Analyze reports and recommend corrective action.

Skills

Quality Assurance

Process Failure Mode and Effects Analysis (PFMEA)

Statistical analysis

Project management

Education

Bachelor's degree in Engineering or related field

Advanced degree

Tools

ISO standards

Electronic devices and PCBAs

Job description

A global healthcare company is seeking a Senior Quality Engineer to oversee QA processes for innovative medical devices. The ideal candidate will have at least 5 years of experience in quality assurance and a bachelor's degree in engineering. Responsibilities include leading quality efforts, developing standards, and supporting FDA inspections. The role offers a competitive salary and a comprehensive benefits package.