Director of Quality & Regulatory Excellence

Elucent Medical Inc.; Eden Prairie (MN); On-site; USD 155,000 - 170,000; Full time

Benefits offered by this job

401(k)

Health insurance

Dental insurance

Vision insurance

Paid Holidays

Paid Vacation Days

Short Term Disability

Long Term Disability

Job summary

Elucent Medical Inc. in Eden Prairie, MN is looking for a Director of Quality. This role oversees the Quality Management System and product quality performance, ensuring compliance with FDA and ISO standards.

With a focus on continuous improvement, the Director will lead a high-performing quality team, implement quality practices across various departments, and report on quality metrics to executive leadership. Comprehensive benefits and a full-time schedule are offered.

Qualifications

• 10+ years of experience in FDA-regulated quality roles.
• Expert knowledge of QMS regulatory requirements.
• Experience managing and scaling quality teams.

Responsibilities

• Oversee implementation of QMS and ensure compliance with standards.
• Lead quality management for product lifecycle.
• Manage quality team and training initiatives.

Skills

Product quality outcomes and metrics

Leadership across QMS

Analytical and data-driven skills

Proficiency with eQMS tools

Communication skills

Education

Bachelor’s degree in life science or engineering

Tools

eQMS tools

Job description

Elucent Medical Inc. in Eden Prairie, MN is looking for a Director of Quality. This role oversees the Quality Management System and product quality performance, ensuring compliance with FDA and ISO standards.

With a focus on continuous improvement, the Director will lead a high-performing quality team, implement quality practices across various departments, and report on quality metrics to executive leadership. Comprehensive benefits and a full-time schedule are offered.