Medical Device Quality Director: Catheter & Compliance

EPS Connects LLC; Kentucky; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Relocation assistance

Opportunities for long-term career growth

Job summary

A growing technology-driven medical device manufacturer is seeking a Manufacturing Quality Director with extensive experience in overseeing quality functions and ensuring regulatory compliance. This role will lead initiatives in catheter assembly processes and drive quality improvements across the organization. The ideal candidate should have a deep understanding of ISO 13485 and FDA regulations, along with strong leadership skills to develop cross-functional teams.

Qualifications

• 10+ years of progressive experience in medical device manufacturing quality.
• Proven leadership in catheter assembly or interventional device manufacturing.
• Experience with process validation and cleanroom operations.

Responsibilities

• Lead the Manufacturing Quality organization.
• Oversee process validation and ensure compliance.
• Provide guidance for catheter assembly processes.

Skills

Leadership in quality management

Knowledge of ISO 13485

Strong communication skills

Problem-solving skills

Education

Bachelor’s degree in Engineering or Life Sciences

Advanced degree preferred

Job description

A growing technology-driven medical device manufacturer is seeking a Manufacturing Quality Director with extensive experience in overseeing quality functions and ensuring regulatory compliance. This role will lead initiatives in catheter assembly processes and drive quality improvements across the organization. The ideal candidate should have a deep understanding of ISO 13485 and FDA regulations, along with strong leadership skills to develop cross-functional teams.