Project Manager QMS (m,w,d)

Spring projects are still coming in strong as one of my clients, leader in medical technology worldwide , needs a Project Manager for the area of Quality Management Systems . Feel free to take a look at the details for your consideration and get in touch!

Tasks

• Lead the design, development, harmonization, and global implementation of a Quality Management System (QMS) across multiple regions (EMEA, North America, Latin America, APAC), ensuring alignment with ISO 13485, ICH Q10, EU MDR, and MDSAP requirements for Class I and II medical devices.
• Own and moderate Change Review Board activities, including scheduling regular meetings, collecting and consolidating inputs, facilitating decision‑making, documenting outcomes, and tracking follow‑up actions to completion.
• Drive the full QMS project lifecycle, including scoping, gap analysis, design, implementation, transition into operations, and regional localization, in close collaboration with global and local process owners and site representatives.
• Define and manage QMS interfaces with local and legal manufacturing entities, supported by quality agreements, to enable audit readiness, consistent reporting, continuous improvement, and risk‑based governance at both corporate and site levels.
• Manage global QMS project execution, including planning, stakeholder communication, training deployment, risk management, and escalation, to ensure timely delivery of compliant documentation and successful site adoption.
• Identify, assess, and mitigate program risks related to timelines, resourcing, and digital quality systems; elevate constraints and secure additional support or funding where required.
• Coordinate audit readiness activities in collaboration with quality system leadership and audit program stakeholders to ensure alignment of documentation and site preparedness for internal and external audits, including follow‑up on corrective and preventive actions.
• Oversee requirements and interfaces for digital quality and audit management systems, ensuring document control, workflow integrity, and system readiness to support inspections and routine quality operations.

Requisites

• Fulfilled Degree in Life Sciences
• Minimum of five years of hands‑on experience in Quality Assurance and Quality Operations within the medical device sector.
• Proven experience working in regulated environments, including interaction with regulatory authorities and participation in third‑party audits in EU and the US
• Fluent written and spoken English for effective communication in an international, cross‑functional environment.
• Flexibility to travel occasionally as required to support global activities.

Volume: Full‑time

Start: ASAP