Director of Quality

DIRECTOR OF QUALITY

The Director of Quality will oversee the Quality Assurance (QA) and Quality Control (QC) functions for Bosma products, including Class I and Class II medical devices, ensuring compliance with relevant regulatory standards (such as ISO 9001, ISO 13485, and 21 CFR 820, etc). This role is responsible for leading the team in developing, implementing, and maintaining quality systems that guarantee product safety, regulatory compliance, and customer satisfaction.

• Bachelor's degree in a scientific, engineering, or equivalent discipline required.
• A minimum of 10 years' experience in Quality Assurance with an emphasis on working with medical devices or a similarly regulated environment including a demonstrated thorough knowledge of medical device quality systems with direct experience of ISO 9001, ISO 13485, and 21 CFR Part 820
• At least five years' work experience in a leadership role managing the Quality Assurance function
• Extensive experience handling deviations, nonconformances, investigations, root cause analysis, and corrective/preventive action plans.

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 9001.
• Exceptional leadership, team building, and communication skills.
• Proven experience in quality system development and lifecycle management.
• Expertise in Corrective and Preventative Actions (CAPA), nonconformance investigations, internal/external audits, and supplier quality.
• Ability to interpret regulatory requirements and current best practices and apply them pragmatically.
• Strategic thinking with attention to detail and a proactive mindset.

• Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) from development to operations, ensuring compliance with industry regulations and standards.
• Ensure ongoing compliance with FDA, ISO 13485, ISO 9001, and other applicable regulations and standards.
• Lead internal and external audits, including but not limited to ISO audits, FDA inspections, and supplier audits
• Direct the CAPA process, including root cause analysis and effectiveness verification.
• Oversee document control, training programs, complaints, cleanroom certification, calibrations, and change control.
• Establish and monitor quality metrics, KPIs, SOP's, and management review activities.
• Collaborate cross-functionally to support product development and commercialization.
• Develop supplier quality systems and manage supplier audits and qualifications.
• Serve as the quality representative in design and process validations, risk assessments, and regulatory submissions.
• Mentor and lead QA/QC team, ensuring continued development and compliance
• Other duties as assigned