Site Head of Quality

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

Job Summary:

The Site Head of Quality will be responsible for overseeing the development, implementation, and maintenance of our Quality Management System (QMS) to ensure compliance with industry standards and regulatory requirements. This role is critical in driving continuous improvement initiatives and ensuring the highest quality standards for our medical devices.

Key Responsibilities:

• Acts as Management Representative and Person Responsible for Regulatory Compliance (PRRC)


• Develop, implement, and manage the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.


• Lead and manage the Quality Assurance team, providing guidance, training, and performance evaluations.


• Effectively manage external suppliers and distributors.


• Establish quality objectives and key performance indicators (KPIs) to monitor and improve product and process quality.


• Oversee internal and external audit programs, ensuring compliance with regulatory requirements and driving corrective and preventive actions (CAPA).


• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into all stages of product development and production.


• Drive continuous improvement initiatives using quality tools and methodologies such as Six Sigma, Lean, and root cause analysis.


• Manage customer complaints and feedback, ensuring timely and effective resolution of quality issues.


• Prepare and present quality reports to senior management, highlighting trends, risks, and opportunities for improvement.


• Ensure proper documentation and control of quality records in compliance with regulatory and company requirements.


• Stay current with industry trends, regulatory changes, and best practices to ensure ongoing compliance and improvement.

Qualifications:

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


• 5+ years of experience in a quality management role, preferably within the medical device industry.


• In-depth knowledge of QMS standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.


• Proven leadership and team management skills.


• Strong analytical and problem-solving abilities with experience in root cause analysis and CAPA.


• Proficiency in statistical analysis tools and software (e.g., Minitab)


• Excellent verbal and written communication skills.


• Strong organizational skills and attention to detail.


• Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma) is a plus.