Associate Director of Quality

Meet Life Sciences Ltd.; New York (NY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Meet Life Sciences Ltd. in the United States seeks an experienced Quality leader with a strong medical device background to support quality initiatives and bridge quality requirements with business objectives.

The role leads quality systems, audits, CAPA, risk management, and change control; collaborates with cross-functional teams; travel to Long Island for hybrid engagement.

Qualifications

• Lead and support quality systems, audits, CAPA and change control.
• Strong knowledge of ISO 9001, ISO 13485, ISO 17025.
• Balance quality requirements with business needs and operations.
• Willingness to travel to Long Island for hybrid engagement.

Responsibilities

• Lead and support quality systems and audits.
• Manage CAPA, risk management and change control.
• Drive continuous improvement using PDCA and batch testing.
• Collaborate with cross-functional teams and stakeholders.
• Travel to Long Island for hybrid engagement.

Skills

Quality leadership

CAPA

Risk management

PDCA

Change control

Tools

ISO 9001

ISO 13485

ISO 17025

Job description

Seeking an experienced Quality leader with a strong medical device background to support Quality initiatives and serve as a key bridge between technical Quality requirements and business objectives.

Key Responsibilities & Qualifications:

• Lead and support Quality systems, audits, CAPA, risk management, continuous improvement, PDCA, batch testing, and change control activities.
• Strong knowledge of ISO 9001, ISO 13485, ISO 17025, and other applicable industry frameworks.
• Bring strong business acumen and the ability to balance Quality requirements with the organization's operational and business needs.
• Comfortable challenging decisions and saying “no” when necessary to protect Quality and compliance standards.
• Collaborative, relationship-oriented leader who can work effectively with cross-functional teams and stakeholders.
• Associate Director through Director-level experience preferred.
• Candidates should be based in New York or on the East Coast and open to traveling to Long Island for a hybrid engagement.