Legacy MEDSearch
Overview
Senior Director of Global Quality to set the strategy and lead all aspects of Quality Engineering, Quality Assurance, and Quality Control for a multi-site, global operation in medical devices. This executive will be the primary architect and driver of global audit readiness — ensuring that the company consistently meets or exceeds the requirements of FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, TGA, and Health Canada. Build proactive inspection readiness into the company's culture and processes, delivering favorable outcomes under high scrutiny and maintaining a reputation for quality excellence with regulators, customers, and partners. Responsibilities
Audit Preparedness (Highest Priority)
Lead all activities related to global inspection readiness, including mock audits, remediation planning, and direct participation in FDA, Notified Body, and other regulatory inspections. Ensure inspection readiness is integrated into daily operations, not treated as a one-off event. Serve as the senior point of contact during regulatory inspections, managing on-site interactions, documentation, and post-inspection responses. Direct a geographically dispersed Quality organization across North America, Europe, and APAC. Align team structures and processes across multiple facilities to ensure consistency and compliance. Mentor and develop regional Quality leaders for succession readiness. SaMD / Software QA
Oversee Quality programs for software-based medical devices, ensuring compliance with IEC 62304, CSV, and digital health quality system requirements. Partner with R&D to embed regulatory and quality requirements into software design, verification, and validation. Lead supplier quality management for OEMs, contract manufacturers, and critical component providers. Implement robust qualification, auditing, and corrective action systems. Drive quality integration in New Product Introduction processes to ensure compliant, on-time launches. Quality Engineering & Assurance
Maintain strong design control and risk management processes from concept to commercialization. Ensure robust labeling, design transfer, and technical documentation processes across product lines. Manage global QMS activities, including document control, CAPA, change control, and validation programs. Quality Control
Oversee receiving inspection, in-process and final inspections, calibration, and nonconformance management. Lead the Material Review Board and ensure QC records are compliant and audit-ready. Establish meaningful KPIs and Quantifiable Quality Objectives (QQOs) to measure effectiveness and compliance. Integrate voice-of-customer (VOC) feedback into continuous improvement initiatives. Requirements
Bachelor's degree in Engineering, Quality, Life Sciences, or related field (Master's, MBA, or ASQ certifications preferred). Minimum 12 years in regulated medical device Quality leadership, with at least 8 years in global, multi-site management. Demonstrated track record of leading regulatory inspections with favorable outcomes. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, TGA, Health Canada; SaMD and IEC 62304 experience strongly desired. Proven ability to lead supplier quality programs and NPI quality integration. Skilled in developing high-performing global teams, fostering cross-cultural collaboration. Excellent executive-level communication skills, with the ability to represent Quality at the highest levels internally and externally. Location:
Pacific Northwest (Hybrid) Travel:
~10% International This job description may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs. Legacy MedSearch has been consecutively featured on Forbes' list of Best Recruiting Firms in America for 6 years running (2019–2024).
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Senior Director of Global Quality to set the strategy and lead all aspects of Quality Engineering, Quality Assurance, and Quality Control for a multi-site, global operation in medical devices. This executive will be the primary architect and driver of global audit readiness — ensuring that the company consistently meets or exceeds the requirements of FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, TGA, and Health Canada. Build proactive inspection readiness into the company's culture and processes, delivering favorable outcomes under high scrutiny and maintaining a reputation for quality excellence with regulators, customers, and partners. Responsibilities
Audit Preparedness (Highest Priority)
Lead all activities related to global inspection readiness, including mock audits, remediation planning, and direct participation in FDA, Notified Body, and other regulatory inspections. Ensure inspection readiness is integrated into daily operations, not treated as a one-off event. Serve as the senior point of contact during regulatory inspections, managing on-site interactions, documentation, and post-inspection responses. Direct a geographically dispersed Quality organization across North America, Europe, and APAC. Align team structures and processes across multiple facilities to ensure consistency and compliance. Mentor and develop regional Quality leaders for succession readiness. SaMD / Software QA
Oversee Quality programs for software-based medical devices, ensuring compliance with IEC 62304, CSV, and digital health quality system requirements. Partner with R&D to embed regulatory and quality requirements into software design, verification, and validation. Lead supplier quality management for OEMs, contract manufacturers, and critical component providers. Implement robust qualification, auditing, and corrective action systems. Drive quality integration in New Product Introduction processes to ensure compliant, on-time launches. Quality Engineering & Assurance
Maintain strong design control and risk management processes from concept to commercialization. Ensure robust labeling, design transfer, and technical documentation processes across product lines. Manage global QMS activities, including document control, CAPA, change control, and validation programs. Quality Control
Oversee receiving inspection, in-process and final inspections, calibration, and nonconformance management. Lead the Material Review Board and ensure QC records are compliant and audit-ready. Establish meaningful KPIs and Quantifiable Quality Objectives (QQOs) to measure effectiveness and compliance. Integrate voice-of-customer (VOC) feedback into continuous improvement initiatives. Requirements
Bachelor's degree in Engineering, Quality, Life Sciences, or related field (Master's, MBA, or ASQ certifications preferred). Minimum 12 years in regulated medical device Quality leadership, with at least 8 years in global, multi-site management. Demonstrated track record of leading regulatory inspections with favorable outcomes. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, TGA, Health Canada; SaMD and IEC 62304 experience strongly desired. Proven ability to lead supplier quality programs and NPI quality integration. Skilled in developing high-performing global teams, fostering cross-cultural collaboration. Excellent executive-level communication skills, with the ability to represent Quality at the highest levels internally and externally. Location:
Pacific Northwest (Hybrid) Travel:
~10% International This job description may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs. Legacy MedSearch has been consecutively featured on Forbes' list of Best Recruiting Firms in America for 6 years running (2019–2024).
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