Site Head of Quality

Trinity Biotech; Kansas City (MO); On-site; USD 120,000 - 190,000; Full time

Job summary

Trinity Biotech seeks a Site Head of Quality to oversee the development, implementation, and maintenance of the Quality Management System ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. This role drives continuous improvement and upholds the highest quality standards for medical devices.

You will lead the QA team, manage supplier relationships, monitor KPIs, supervise audits and CAPA, and collaborate with R&D, manufacturing, and regulatory affairs to ensure quality is embedded across

Qualifications

• Proven leadership in a quality function within medical devices.
• Experience implementing and maintaining QMS per ISO 13485 and FDA 21 CFR Part 820.
• Strong analytical and problem-solving abilities with CAPA proficiency.
• Ability to supervise audits and drive continuous improvement using Lean/Six Sigma.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Acts as Management Representative and PRRC.
• Develop, implement, and manage the QMS per ISO 13485 and FDA 21 CFR Part 820.
• Lead and manage the Quality Assurance team with guidance and evaluations.
• Effectively manage external suppliers and distributors.
• Establish quality objectives and KPIs to monitor quality.
• Oversee internal and external audit programs and CAPA.
• Collaborate with R&D, manufacturing, and regulatory affairs to embed quality in development and production.
• Drive continuous improvement with Six Sigma, Lean, and root cause analysis.
• Manage customer complaints and feedback for timely resolution.
• Prepare quality reports highlighting trends, risks, and improvement opportunities.
• Ensure documentation and control of quality records in compliance with regulations.

Skills

Leadership

Quality management

Analytical skills

CAPA

Statistical analysis

Minitab

Communication

Education

Bachelor's degree in Quality Assurance, Engineering, Life Sciences

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.