A leading medical device consulting firm is seeking a Quality Systems Lead to manage QMS operations and guide client companies navigating complex regulatory environments.
Key Responsibilities:
QMS Management: Maintain and optimize QMS in compliance with ISO 13485, EU MDR, IVDR, QMSR, and ISO 27001.
Quality Processes: Drive CAPA, Non-Conformances (NC), Complaints, Deviations, and Change Control.
Documentation Audits: Oversee Document Control (DHF/DMR/DHR), lead Management Reviews, and manage ISO 13485 / MDR / IVDR audits.
Supplier Operations Quality: Manage supplier quality (ASL, SCAR, QAA), support product releases, QC testing, calibration, and operational controls.
Cross-Functional Collaboration: Partner closely with clients and multidisciplinary internal teams (R D, Operations, Regulatory).
Requirements: Technical or scientific degree.
5+ years of quality management experience in the medical device industry.
Hands-on experience with EU Class IIb / Class III medical devices.
Proven experience with ISO 13485, EU MDR, and IVDR, including audit leadership.
Practical experience with QMS, CAPA, NC, Deviations, Change Control, and Document Control.
Ability to combine a systemic perspective and professional leadership with hands-on execution.
Experience working with clients and managing multiple projects simultaneously.
Excellent English communication skills.
Experience with Gamma / EtO sterilization processes - a significant advantage.
This position is open to all candidates.