Quality Assurance Manager

Boston Aesthetics is backed by Peninsula Medical Group (PMG), a global leader in energy-based medical aesthetics with more than $350M in annual revenue, 400+ R&D engineers, and 100,000+ devices installed across 10,000+ clinics worldwide.

Our mission is defined by the “Beauty with No Boundary” philosophy: delivering technologies designed to rebalance patient comfort and clinical outcomes,

We are building a dynamic U.S. team that thrives at the intersection of technology, clinical outcomes, and business impact.

Joining Boston Aesthetics means becoming part of a fast-growing organization, backed by world-class R&D, a proven track record in Asia, and a vision to redefine the future of aesthetics in the U.S. and beyond.

Our parent company, PMG oversees product design, manufacturing, and global quality systems.

We are seeking a hands‑on Quality Manager, mainly supporting U.S. quality and regulatory compliance, ensuring safe and compliant distribution of our products and supporting post‑market quality activities.

This role is ideal for someone experienced in medical device quality, complaint handling, and FDA compliance
, who enjoys working in a collaborative and growing commercial organization.

The Quality Manager will be responsible for developing and maintaining the U.S. Quality Management System (QMS) related to commercial operations, including complaint handling, distribution controls, audit support, and post‑market quality activities. This role will work closely with the global Quality team and serve as the primary Quality representative for the U.S. entity.

The role does not require oversee of design control or manufacturing quality operations, but it is accountable for ensuring adherence to FDA regulations for medical device import and compliant handling in the U.S. market.

• Manage customer complaints in accordance with FDA requirements and internal procedures
• Coordinate complaint investigations with global Quality and Engineering teams
• Support Medical Device Reporting (MDR) assessments and regulatory reporting as required
• Maintain complaint files and ensure timely closure and documentation

• Ensure compliant handling, storage, and distribution of medical devices
• Maintain product traceability, including serial and lot tracking
• Support field actions, corrections, and recalls if necessary
• Ensure quality controls related to logistics, warehousing, and distribution

• Develop and Maintain local QMS procedures, records, and document control systems
• Ensure compliance with applicable FDA Quality System Regulation requirements
• Support training programs and ensure proper documentation of employee training

• Serve as the primary Quality contact for FDA inspections and external audits of the U.S. entity
• Support internal audits and compliance reviews
• Coordinate with global Quality teams to ensure alignment and audit readiness

• Partner with Sales, Service, Operations, clinical and Regulatory teams to ensure compliance
• Act as liaison between U.S. commercial operations and global Quality organization
• Promote a culture of quality and compliance across the U.S. team

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 5–8+ years of experience in Quality Assurance within the medical device industry
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820)
• Experience with ISO 13485 Quality Management Systems
• Experience with complaint handling and post‑market quality processes
• Experience supporting FDA inspections or external audits
• Strong documentation, organizational, and communication skills
• Authorized to work in the United States

• Experience supporting medical device distributors or commercial subsidiaries
• Experience with medical aesthetics or capital equipment medical devices
• Experience working with global or overseas manufacturing partners

• Opportunity to play a key quality leadership role in a growing U.S. organization
• Collaborative partnership with an experienced global Quality team
• High visibility and meaningful impact on patient safety and regulatory compliance
• Competitive compensation and benefits aligned with California market standards

This role is well suited for candidates currently working as:

• Quality Manager
• Quality Assurance Manager
• Senior Quality Engineer
• Post‑Market Quality Engineer
• Complaint Handling Quality Engineer

within a medical device company, distributor, or commercial organization.