Senior QA Engineering Leader for Medical Devices

Prismatik; Irvine (CA); On-site; USD 114,000 - 152,000; Full time

Job summary

Prismatik in Irvine, CA is seeking an experienced Quality Assurance Director to lead product quality and regulatory compliance across development and contract manufacturing for medical products. This onsite role requires strong leadership and a proven track record in ISO 13485 and SaMD.

You will oversee a robust quality system, mentor staff, drive process improvements, manage audits, and coordinate with engineering and manufacturing to ensure timely delivery and adherence to standards.

Qualifications

• Minimum seven years of related quality assurance experience.
• Previous management and leadership experience.
• Experience with ISO 13485 and SaMD regulatory requirements.
• Experience with development, testing, and manufacturing of medical products.

Responsibilities

• Ensures products meet customer requirements and complies with US and international regulations.
• Manages new product development and process improvement projects.
• Hires, trains, develops, and reviews staff; sets goals for department.
• Coaches team in problem solving, decision making and process improvement.
• Addresses employee relations matters in coordination with HR.
• Maintains a complete and comprehensive quality system for development and contract manufacturing.
• Oversees quality system processes during new product introductions.
• Evaluates manufacturing processes to ensure quality and timely project flow.
• Implements inspection, testing, and evaluation methods for products and equipment.
• Participates in audits and ensures SOPs and policies are followed.

Skills

Quality assurance

Leadership

Problem solving

Regulatory compliance

Education

Bachelor’s degree in a related engineering discipline

Job description

Prismatik in Irvine, CA is seeking an experienced Quality Assurance Director to lead product quality and regulatory compliance across development and contract manufacturing for medical products. This onsite role requires strong leadership and a proven track record in ISO 13485 and SaMD.

You will oversee a robust quality system, mentor staff, drive process improvements, manage audits, and coordinate with engineering and manufacturing to ensure timely delivery and adherence to standards.