Site Quality Leader: QMS, Compliance & CAPA

Trinity Biotech; Jamestown (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Trinity Biotech is seeking a Site Head of Quality to oversee the development, implementation, and maintenance of the Quality Management System (QMS) ensuring compliance with ISO 13485 and FDA regulations for medical devices.

You will lead the QA team, manage supplier relationships, drive continuous improvement with Six Sigma and Lean, and partner with R&D, manufacturing, and regulatory affairs to embed quality in every stage of product development.

Qualifications

• Bachelor’s degree in QA, Engineering, Life Sciences, or related field.
• 5+ years in quality management, medical device preferred.
• Deep knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Strong leadership and team management skills.
• Proven problem-solving with CAPA/root cause analysis.
• Experience with statistical tools (Minitab).
• Excellent verbal and written communication.
• Strong organizational skills and attention to detail.
• Quality management certifications are a plus (ASQ, Six Sigma).

Responsibilities

• Act as Management Representative and PRRC.
• Develop, implement, and manage the QMS per ISO13485 and FDA 21 CFR Part 820.
• Lead and manage the QA team with training and evaluations.
• Manage external suppliers and distributors.
• Set quality objectives and KPIs to monitor and improve quality.
• Oversee audit programs and CAPA compliance.
• Collaborate with R&D, manufacturing, regulatory affairs.
• Drive continuous improvement using Six Sigma, Lean, RCA.
• Manage customer complaints and feedback.
• Prepare and present quality reports to senior management.
• Ensure documentation and control of quality records.
• Stay current with industry trends and regulatory changes.

Skills

Leadership

Analytical thinking

Problem solving

Communication skills

Organizational skills

CAPA

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in Quality Assurance, Engineering, Life Sciences, or related field

Tools

Minitab

Job description

Trinity Biotech is seeking a Site Head of Quality to oversee the development, implementation, and maintenance of the Quality Management System (QMS) ensuring compliance with ISO 13485 and FDA regulations for medical devices.

You will lead the QA team, manage supplier relationships, drive continuous improvement with Six Sigma and Lean, and partner with R&D, manufacturing, and regulatory affairs to embed quality in every stage of product development.