QA Leader
il y a 15 heures
Job Description SummaryQA Leader – Region / Responsable Assurance Qualité – Région (H/F)As QA Leader in the International Region QA team, you will lead and coordinate all Quality Assurance (QA) activities across the French‑speaking countries in Zone Vega (France, Belgium, Luxemburg, French‑speaking Africa – this geographic scope may broaden). Vega is a key developed market, and this role is critical to ensuring quality and regulatory compliance across diverse geographies and business models.You will be responsible for implementing and maintaining the Quality Management System (QMS), supporting audits and inspections, and acting as the primary QA interface for Sales and Service teams in the zone. You will collaborate closely with the regional Regulatory Affairs team, QA peers in the VEGA Zone & INTERNATIONAL region, as well as global quality functions to ensure alignment with standards and global expectations.Roles and ResponsibilitiesAct as the focal point for QA in the Vega Zone, supporting Sales, Service, and operational teams.Participate in the maintenance and update of the QMS, including Site Quality Plans (SQPs), local procedures, and training compliance.Ensure understanding and adherence to quality procedures across the Region.Lead and support internal and external audits, including regulatory inspections.Monitor and report on QMS training status; co‑accountable for training completion in the zone.Coach and mentor teams on the development, maintenance, and simplification of local procedures.Provide guidance to business managers on quality topics and regulatory expectations.Drive the CAPA process by identifying quality concerns, conducting spot audits, and ensuring timely corrective actions.Lead or support quality improvement projects and QPTPs (e.g., repair center setup, office moves, harvesting).Manage deviation/concession processes and ensure compliance with tool calibration and OOT requirements.Support channel partner quality oversight, including Annex Q adherence and audit readiness.Collaborate with the Supplier Quality team to ensure use of qualified suppliers.Support closure of customer complaints, field actions, and non‑conformances.Participate in remote internal audits as lead auditor or SME.Collaborate with the regional RA team to ensure alignment on regulatory requirements, audit readiness, and product compliance. Represent the Vega zone in INTERNATIONAL region and global QA forums and initiatives.Required QualificationsBachelor’s degree in engineering, Life Sciences, Quality, or a related technical field.Experience in Quality Assurance within the medical device, healthcare, or regulated industry.Strong knowledge of ISO 13485, EU MDR, and other applicable international regulations.Experience in internal and external audits, including regulatory inspections.Proven ability to manage QMS documentation, training, and compliance activities.Fluent and proficient in French (spoken and written).Excellent English communication skills (written and spoken).Strong organizational, analytical, and leadership skills.Ability to work and travel independently and collaboratively across diverse cultures and geographies.Desired CharacteristicsAdvanced degree (e.g., MSc, MBA) or professional certifications (e.g., ASQ CQA, Lead Auditor).Experience in a regional QA leadership role.Familiarity with Sales and Service operations in French‑speaking countries in Europe and North Africa.Experience with CRM systems, field service quality, and digital tools.Lean/Six Sigma certification or experience with continuous improvement.Cultural agility and ability to influence across functions and levels.Willingness to travel across the region as needed.Additional InformationRelocation Assistance Provided: NoSeniority levelMid‑Senior levelEmployment typeFull‑timeJob functionQuality AssuranceIndustriesHospitals and Health CareInclusion & Diversity statementGE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.About UsGE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world‑changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. #J-18808-Ljbffr
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QA Leader
il y a 1 jour
Buc, Île-de-France GE HealthCare Temps pleinJob Description SummaryAs QA Leader in the International Region QA team, you will lead and coordinate all Quality Assurance (QA) activities across the French speaking countries in Zone Vega (France, Belgium, Luxemburg, French speaking Africa - this geographic scope could be broadened). Vega is a key developed market, and this role is critical to ensuring...
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il y a 3 jours
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