Senior Quality Systems SME – ISO 13485 & Audits

huMannity Medtec; Santa Clarita (CA); On-site; USD 94,000 - 105,000; Full time

Benefits offered by this job

9/80 schedule with every other Friday

26 long weekends per year

Weekly team lunches

Monthly events

Growth and learning opportunities

Job summary

huMannity Medtec is seeking a Senior Quality Systems Specialist in Santa Clarita, CA to drive the Quality Management System in compliance with ISO 13485:2016 and regulatory requirements. The role partners with R&D, Manufacturing, QA, and cross-functional teams to foster a culture of quality and continuous improvement.

The successful candidate will oversee internal audits, lead CAPA activities, and develop quality metrics and dashboards to support executive decision-making.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• Minimum of 10 years of combined practical and educational experience within the medical device industry.
• Hands-on experience maintaining and improving Quality Management Systems.
• Strong working knowledge of ISO 13485:2016 requirements.
• Excellent technical writing, documentation, and communication skills.
• Experience developing and maintaining SOPs, work instructions, forms, and controlled documents.
• Experience planning, conducting, and supporting internal and external audits.
• Strong analytical, organizational, and problem-solving skills.
• Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Visio, and database systems.
• Ability to manage multiple priorities and work independently.
• Ability to quickly understand complex processes and quality system requirements.

Responsibilities

• Develop, maintain, and improve the Quality Management System in line with ISO 13485 and regulatory requirements.
• Serve as SME for quality systems and guide cross-functional teams.
• Develop, revise, and maintain SOPs, work instructions, forms, and other documents.
• Review and approve quality system documentation for accuracy and compliance.
• Plan, schedule, conduct, and coordinate internal audits and support external audits.
• Support CAPA investigations and effectiveness checks.
• Collaborate with cross-functional teams to resolve quality issues and improve compliance.
• Lead quality system improvement projects and process optimization initiatives.

Skills

Quality systems

Regulatory knowledge

Technical writing

Project management

Analytical thinking

Independent work

Education

Bachelor's degree or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Visio

Database systems

Job description

huMannity Medtec is seeking a Senior Quality Systems Specialist in Santa Clarita, CA to drive the Quality Management System in compliance with ISO 13485:2016 and regulatory requirements. The role partners with R&D, Manufacturing, QA, and cross-functional teams to foster a culture of quality and continuous improvement.

The successful candidate will oversee internal audits, lead CAPA activities, and develop quality metrics and dashboards to support executive decision-making.