Sr Quality Engineer (Medical Devices)

Location: Alameda, California, United States; on-site

Salary: $125,000–$175,000 per year

Company

hirify.global is a global healthcare company that designs, develops, manufactures, and markets medical products for challenging medical conditions.

What you will do

• Participate in the development, qualification, and continuous improvement of new and existing medical device products.
• Lead quality activities in cross-functional project teams covering design, development, manufacturing, and sustaining projects.
• Design and implement inspection, testing, evaluation, and measurement methods, including method validation.
• Monitor design controls, quality standards, QMS processes, and compliance with domestic and global regulations.
• Analyze nonconforming products, returned products, and failure investigations; recommend corrective and preventive actions.
• Support NCR and CAPA boards, QSR training, FDA and notified body audits, SOP development, and quality documentation.

Requirements

• Bachelor’s degree in engineering, life science, or a related field, with 5+ years of relevant experience, including quality assurance and ISO experience.
• Experience in commercial medical device manufacturing or another regulated industry; contract-manufactured medical device experience is required.
• Experience with PFMEA, sustaining projects, NCRs, failure investigations, and change control.
• Ability to work in office, laboratory, and cleanroom environments and move between buildings and floors.
• Ability to lift and move up to 25 pounds, remain stationary for extended periods, and communicate accurately with employees at all levels.

Nice to have

• Advanced degree.
• Experience with auditing, design reviews, sterilization, project management, or product development.

Culture & Benefits

• Collaborative teamwork environment with continuous learning and performance recognition.
• Medical, dental, vision, life, AD&D, short-term and long-term disability insurance.
• 401(k) with employer match, paid parental leave, paid sick time, and eleven paid company holidays.
• At least fifteen accrued vacation days per year, increasing with tenure.
• Business travel of 0–10% and potential exposure to blood-borne pathogens.