Sr. Quality Engineer (Medtech)

TL;DR

Sr. Quality Engineer (Medtech): Participate in process development, supplier development, and manufacturing to ensure highest product quality and regulatory compliance with an accent on detailed analysis, risk management, and continuous improvement. Focus on leading cross-functional teams, CAPA investigations, engineering change orders, and statistical data interpretation for test methods and quality controls.

Roseville, CA

Starting Base Salary: $113,000/year - $157,000/year

Company

Global healthcare company focused on designing, developing, manufacturing, and marketing innovative therapies for challenging medical conditions.

What you will do

• Represent Quality Engineering on cross-functional teams across Manufacturing, QC, R&D, Regulatory, Operations, and Marketing.
• Evaluate and improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
• Own Engineering Change Orders, risk analysis, and documentation.
• Design and implement test/inspection methods and partner with suppliers for quality standards.
• Lead nonconforming investigations, CAPAs, and project teams to meet quality and business objectives.
• Mentor junior staff and ensure compliance with quality systems and regulations.

Requirements

• Bachelor’s degree in Engineering, Life Science, or related field with 5+ years relevant experience in Quality Assurance and ISO.
• Broad knowledge of regulations like QSR, ISO 13485, sterilization, biocompatibility, and shelf-life standards.
• Working knowledge of data analysis, scientific methods, and problem-solving.
• Ability to lead projects, communicate effectively, and adapt to changing priorities.

Nice to have

• Advanced degree.
• Experience in auditing, design review, sterilization, project management, or product development.
• ASQ CQE certification.
• R&D or new product development experience.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Comprehensive benefits: medical, dental, vision, life, AD&D, short/long-term disability, 401(k) with match.
• Paid parental leave, 11 company holidays, 15+ days vacation increasing with tenure, paid sick time.
• Business travel 0-10%, office/lab/cleanroom environments.