QMS Project Manager job opportunity at Zeiss Group.

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DatePosted 30+ Days Ago bot
Zeiss Group QMS Project Manager
Experience: 5-years
Pattern: full-time
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loacation Lisboa, Portugal
loacation Lisboa....Portugal

QMS Project Manager ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 11.8 billion euros in revenue with around 46,000 employees across 50 countries around the globe.  We’re looking for a QMS Project Manager to join our team in Lisbon, Portugal . Your Role As a QMS Project Manager you will: Lead the design, development, harmonization, and implementation of the CZV Quality/ Management System (Q/MS) for application across CZV in EMEA/NA/LA/APAC, ensuring alignment with ISO 13485, ISO 9001, ICH Q10, and MDSAP. Drive the Q/MS project lifecycle (scoping and analysis, design and implementation, transition and localization), coordinating authoring and implementation with Global Process Owners (GPOs), Local Process Owners (LPOs), and SMEs. Identify and establish clear Q/MS interfaces to local/legal manufacturers, covered by QAA and support readiness for corporate and site certification audits, and enable consistent reporting, continuous improvement, and risk-based governance. Manage project planning, communication, training, stakeholder alignment, and risk mitigation to deliver CQMS documents and site implementations on time and to standard. Your Profile You will have: Education / Professional Certification Completed scientific or engineering education, preferably in Life Sciences industry. Experience 3–5 years in Quality Assurance, Quality Operations for Medical Devices/Medicinal Products. Minimum 3 years’ hands-on experience in development/manufacture/control of medical devices and/or medicinal products. Experience in regulatory environments (e.g., National Regulatory Authorities) and third-party audits (EU Notified Bodies, US FDA). Knowledge / Skills / Other characteristics Standards and regulations: ISO 13485, ISO 9001, EU GMP Guidelines, ICH Q10; device regs (21 CFR 820, ANVISA RDC 16/2013, MHLWM0169, TG(MD)R Sch3, CMDR, MDD 93/42/EC); MDSAP; medicinal product regs (GMP, AMG, AMWHV). Strong project management: multi-region QMS harmonization, stakeholder alignment, risk management, training rollout. Process design and documentation: senior auditor capability; authoring and implementing eQMS processes; software validation knowledge. Systems: SAP, MS Office, Lotus Notes, QDOK, TrackWise, PTC-Windchill or similar. Product knowledge: dialysis therapies and products preferable; TrackWise preferred. Languages: Advanced English. Personal qualities: finisher/completer; team-oriented; effective matrix leadership; collaborative; challenges status quo. Working conditions & Other Attributes. -Willingness to travel domestically and internationally across EMEA/LA/AP. Operates within corporate governance frameworks and applicable regulatory requirements. Executes activities per company rules and guidelines. Your ZEISS Recruiting Team: Joe Taroni

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