💼 About This Role

You'll lead the Quality Management System for a preventive health technology company, ensuring compliance with ISO 13485 and IVDR. You'll drive continuous improvement across product quality and regulatory processes. This role offers leadership of a dedicated team and the chance to shape quality culture.

🎯 What You'll Do

• Develop and maintain the Quality Management System (QMS).
• Lead and mentor the quality assurance team.
• Oversee regulatory compliance including ISO 13485 and IVDR.
• Manage customer complaint investigations and corrective actions.

📋 Requirements

• 6+ years of progressive QA experience.
• 3+ years in a leadership/people management role.
• Extensive knowledge of IVD regulations (IVDR, FDA).
• Experience with ISO 13485 certification.

✨ Nice to Have

• Bachelor's degree in a related field.
• Black Belt certified.
• Experience with budget management and strategic goal setting.

🎁 Benefits & Perks

• 💰 Competitive total compensation (estimated, not stated).
• 🏖️ Generous PTO policy.
• 🏥 Medical, dental, vision insurance (partially company-paid).
• 🦺 Company-provided disability and life insurance.
• 🏢 Flexible schedule and work-from-home policy.