Director of Quality and Compliance

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

Director of Quality & Compliance

Beverly, Massachusetts

Help Build the Next Generation of Global Quality.

EPS Connects is conducting a confidential search on behalf of a global medical device manufacturer seeking a Director of Quality & Compliance to help shape the future of its enterprise Quality Management System.

This is not a traditional Quality Director role focused on maintaining compliance. The organization has experienced significant growth, and they’re looking for a leader who can help evolve their Quality Management System to support the next stage of that growth.

Working closely with the Vice President of Quality, you’ll evaluate existing quality systems, identify opportunities for improvement, harmonize processes across global manufacturing sites, and help build a scalable quality organization capable of supporting continued expansion.

If you’re energized by improving systems rather than simply maintaining them, this opportunity offers the chance to make a lasting impact.

What You’ll Be Doing

• 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 throughout the organization.
• 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.

We’re Interested In Leaders Who Have

• Progressive leadership experience in medical device manufacturing quality.
• Experience improving or transforming Quality Management Systems—not simply maintaining them.
• Strong understanding of ISO 13485, FDA Quality System Regulation, MDSAP, and global regulatory expectations.
• Experience working across multiple manufacturing sites or global operations.
• Strong collaboration skills with Engineering, Operations, Regulatory Affairs, and executive leadership.
• A practical continuous improvement mindset focused on sustainable progress rather than perfection.
• Excellent communication skills with the ability to influence without relying solely on organizational authority.

Why This Opportunity Stands Out

This position offers the opportunity to work directly with executive leadership while helping shape the future direction of Quality across a growing global organization. The successful candidate will have meaningful influence on systems, strategy, and organizational development—not simply day-to-day compliance.