Global Quality & Compliance Transformation Leader

EPS Connects LLC; Beverly (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

EPS Connects LLC in Beverly, MA is seeking a Director of Quality & Compliance to drive the evolution of a scalable Quality Management System across global manufacturing sites. You will collaborate with executive leadership to shape strategy and implement measurable quality improvements.

The role requires deep knowledge of ISO 13485, FDA QSR, MDSAP, and continuous improvement, with strong communication and cross-functional influence across Operations, Regulatory Affairs, and Engineering.

Qualifications

• Progressive leadership experience in medical device quality management.
• Experience transforming Quality Management Systems, not just maintaining them.
• Strong understanding of ISO 13485, FDA QSR, MDSAP and global regulatory expectations.
• Experience working across multiple manufacturing sites or global operations.
• Strong collaboration with Engineering, Operations, Regulatory Affairs and leadership.
• Practical continuous improvement mindset focused on sustainable progress.
• Excellent communication skills with influence beyond formal authority.

Responsibilities

• Evaluate and improve an enterprise Quality Management System supporting multiple global manufacturing sites.
• Drive practical, measurable improvements to quality processes, systems, and performance metrics.
• Partner with Operations, Engineering, Regulatory Affairs, and executive leadership to strengthen quality.
• Lead quality initiatives involving FDA, ISO 13485, MDSAP, and other global regulatory requirements.
• Support quality harmonization across manufacturing locations.
• Build dashboards and meaningful quality metrics that drive better business decisions.
• Mentor and influence quality leaders throughout the organization.
• Help develop the long-term quality strategy for a growing global medical device company.

Skills

Leadership in medical device quality

Quality Management Systems

ISO 13485 knowledge

FDA QSR knowledge

MDSAP knowledge

Cross-site collaboration

Continuous improvement mindset

Influence without authority

Communication skills

Job description

EPS Connects LLC in Beverly, MA is seeking a Director of Quality & Compliance to drive the evolution of a scalable Quality Management System across global manufacturing sites. You will collaborate with executive leadership to shape strategy and implement measurable quality improvements.

The role requires deep knowledge of ISO 13485, FDA QSR, MDSAP, and continuous improvement, with strong communication and cross-functional influence across Operations, Regulatory Affairs, and Engineering.