Responsibilities:

• Manage relationships with clients and stakeholders.
• Develop project scopes and objectives, involving relevant stakeholders.
• Create, maintain, and approve work plans.
• Coordinate internal resources and third-party vendors.
• Ensure projects are delivered on time and within scope.
• Report and escalate issues to management as needed.
• Oversee QA and RA management activities, ensuring compliance with relevant regulations (ISO 13485:2016, MDD, EU MDR, 21 CFR 821, etc.).
• Assist with regulatory processes, supplier control, performance monitoring, management review, QMS monitoring and analysis, and ongoing maintenance of quality processes (MRB, ECO, CAPA, failure investigations, calibrations).
• Support production processes (work instructions, design transfer, DMR, DHR).
• Assist with design control and V&V.
• Assist with internal and supplier quality system, process, and product audits.

Job Requirements:

• Bachelor’s degree in Engineering or Life Sciences.
• 5+ years of experience as a QA/RA team manager in the medical device industry.
• Demonstrated knowledge of regulatory issues and experience with regulatory bodies (FDA, European competent authorities, notified bodies, Health Canada, etc.).
• Experience with routine QA/QC activities (CAPA, MRB, ECO, RMA, SCAR).

Skills/Training:

• Strong management skills, including prioritization, planning, evaluation, and execution.
• Demonstrated knowledge of quality management systems, continuous improvement methodologies, and in-depth understanding of site-level products and processes.
• Proficiency in English.