Harba Solutions Inc.
Base pay range
$130,000.00/yr - $160,000.00/yr
Responsibilities
Design, develop, and implement a comprehensive, facility-wide Quality Management System aligned with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR 2017/745
Build scalable quality system procedures that accommodate diverse client requirements across U.S., European, and global markets
Establish and maintain Quality Manuals, SOPs, and process documentation supporting contract manufacturing activities for both U.S. and EU-regulated products
Draft and manage quality agreements and technical agreements defining roles, responsibilities, and compliance expectations for global market distribution
Implement design control and GMP‑compliant manufacturing quality systems supporting combination product and device regulatory requirements
Lead internal quality system assessments and collaborate with external auditors to demonstrate regulatory compliance readiness (FDA, ISO, EU MDR/Notified Body)
Develop and maintain risk management processes in alignment with ISO 14971 and EU MDR requirements
Partner with cross‑functional teams—such as technical services, validation, and operations—to ensure design control, risk management, and Quality System expectations are embedded throughout product lifecycle
Provide technical quality support for investigations, continuous improvement, and routine production activities across multiple programs and products
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related technical discipline (advanced degree preferred)
5–7+ years of experience in medical device or combination product quality systems
Demonstrated experience managing QMS elements to meet U.S. and European regulatory requirements
Strong working knowledge of FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR 2017/745
Familiarity with EMA expectations, MDCG guidance, and Notified Body pathways
Experience supporting CE Marking activities, technical documentation, and Authorized Representative interactions
Solid understanding of ISO 14971 risk management principles
Proven ability to communicate effectively with clients and stakeholders across different regulatory cultures
Experience supporting regulatory submissions by providing QMS documentation required for FDA, EMA, and/or Notified Body review
Ability to manage change controls for medical device and combination product programs within a regulated change control framework
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering, Science, and Manufacturing
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Benefits
Medical insurance
401(k)
Vision insurance
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Responsibilities
Design, develop, and implement a comprehensive, facility-wide Quality Management System aligned with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR 2017/745
Build scalable quality system procedures that accommodate diverse client requirements across U.S., European, and global markets
Establish and maintain Quality Manuals, SOPs, and process documentation supporting contract manufacturing activities for both U.S. and EU-regulated products
Draft and manage quality agreements and technical agreements defining roles, responsibilities, and compliance expectations for global market distribution
Implement design control and GMP‑compliant manufacturing quality systems supporting combination product and device regulatory requirements
Lead internal quality system assessments and collaborate with external auditors to demonstrate regulatory compliance readiness (FDA, ISO, EU MDR/Notified Body)
Develop and maintain risk management processes in alignment with ISO 14971 and EU MDR requirements
Partner with cross‑functional teams—such as technical services, validation, and operations—to ensure design control, risk management, and Quality System expectations are embedded throughout product lifecycle
Provide technical quality support for investigations, continuous improvement, and routine production activities across multiple programs and products
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related technical discipline (advanced degree preferred)
5–7+ years of experience in medical device or combination product quality systems
Demonstrated experience managing QMS elements to meet U.S. and European regulatory requirements
Strong working knowledge of FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR 2017/745
Familiarity with EMA expectations, MDCG guidance, and Notified Body pathways
Experience supporting CE Marking activities, technical documentation, and Authorized Representative interactions
Solid understanding of ISO 14971 risk management principles
Proven ability to communicate effectively with clients and stakeholders across different regulatory cultures
Experience supporting regulatory submissions by providing QMS documentation required for FDA, EMA, and/or Notified Body review
Ability to manage change controls for medical device and combination product programs within a regulated change control framework
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Engineering, Science, and Manufacturing
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Benefits
Medical insurance
401(k)
Vision insurance
#J-18808-Ljbffr