Sr. Quality Manager

Job Title: QA Manager/ Quality Assurance Manager

Location: Mountain View, CA

Introduction

The Quality Assurance department is dedicated to ensuring safe, reliable, and effective products that exceed expectations. This department plays a crucial role in maintaining product and process quality, supporting commercial production for all products including laser consoles, delivery devices, and accessories.

Required Skills & Qualifications

• Applicants must be able to work directly for Artech on W2
• Bachelor’s Degree
• Minimum 5-7 years of Quality Assurance experience with at least 2 years in the medical device industry
• 2 years of experience managing people/teams
• Advanced problem-solving skills including troubleshooting and root cause analysis
• Ability to communicate complex technical issues clearly in English both verbally and in writing
• Demonstrated understanding of medical device QMS requirements and regulatory requirements, including ISO 13485:2016, 21CFR820, and MDSAP
• Familiarity with risk management tools
• Knowledge of quality system auditing; auditing certifications (e.g. lead auditor, quality auditor, biomedical auditor) are a plus

Preferred Skills & Qualifications

• Good documentation skills and attention to detail
• Experience with analytical, statistical, and trending analyses on complaint data
• Ability to recommend improvements in quality systems to ensure efficiency and effective controls

Day-to-Day Responsibilities

• Oversee a dedicated Quality Assurance team, providing guidance and direction across operational and functional areas
• Identify areas for process improvements and collaborate with management to develop effective solutions
• Manage and plan internal audits collaboratively with the Director of Regulatory Affairs
• Manage supplier quality assurance activities, including supporting new supplier approval and monitoring performance of existing suppliers
• Perform analyses on complaint data to support timely management review and proactive corrective action
• Review/write product investigation reports and provide analyses and trending data
• Ensure the Quality Management System is established, implemented, and maintained in accordance with regulations
• Develop formal written reports to communicate audit results to management and regulatory compliance agencies
• Escalate quality issues that could impact safety or efficacy
• Perform other duties as assigned by management

Company Benefits & Culture

• Inclusive and diverse work environment
• Opportunities for professional growth and development
• Supportive team culture

For immediate consideration please click APPLY to begin the screening process with Alex/ reach me at gracy.ingle@artech.com