Job Description

A fast-growing leader in consumer-focused Class II medical devices and wellness products is seeking a Quality Manager to lead and strengthen its global Quality Management System (QMS).

This company designs FDA-cleared laser-based therapies and nutritional supplements that impact tens of thousands of customers each year - and quality is at the heart of it all.

We’re looking for a hands-on Quality leader who thrives in fast-paced, high-growth environments and is energized by building scalable systems that ensure compliance, safety, and product excellence. If you have deep regulatory knowledge and are passionate about empowering teams through smart processes and continuous improvement, this could be your next big role.

What You’ll Be Doing

• Lead and improve the QMS to ensure compliance with FDA, ISO 13485, and MDSAP standards.
• Oversee CAPAs, complaints, and nonconformance investigations with a focus on root cause and closure.
• Manage document control, training, and change management systems.
• Own supplier quality processes, including audits, inspections, and agreements.
• Monitor and analyze quality metrics to identify trends and mitigate risk.
• Drive risk management efforts across safety, usability, and performance.
• Support internal audits and regulatory inspections.
• Partner cross-functionally to align quality efforts with product and business goals.
• Train teams on compliance expectations and quality best practices.
• Contribute to management reviews and quality planning activities.

What You Bring

• Bachelor’s degree in engineering, Quality, or related field ( Master’s a plus ).
• 6+ years of quality assurance experience in medical devices, with strong knowledge of global regulatory standards.
• Hands-on experience with FDA inspections , ISO 13485 audits , and MDSAP .
• Skilled in risk analysis , FMEA , design control , and validation .
• Familiarity with aesthetic, dermatology , or energy-based devices is a bonus.
• Strong analytical, leadership, and communication skills.

Bonus if you have:

• ASQ certifications (CQA, CQE), ISO 13485 lead auditor
• Experience with eQMS tools (e.g., Greenlight Guru, MasterControl)
• Knowledge of international regs (EU MDR, ANVISA, Health Canada)
• Lean Six Sigma Black Belt or similar process improvement background

This is your opportunity to lead Quality at a company where your work directly impacts people’s lives and wellbeing. You'll be joining a collaborative and mission-driven team with a passion for innovation and a strong pipeline of new technologies.

For immediate consideration, apply today or contact Scot Widjaja at (213)-262-2064.

Job Tags

Similar Jobs