QA Manager / QA System Engineer

QMS Ownership & Hands-On Operations
QMS Maintenance: Maintain and improve the QMS to ensure full compliance with ISO 13485 and EU /MDR / IVDR / QMSR / ISO 27001
Document Control: Manage the document control process, including Device History Files (DHF) and Device Master Records (DMR).
NC, CAPA & Complaints: Lead investigations for nonconforming products, customer complaints, and Corrective and Preventive Actions (CAPA).
Core Processes: Execute daily activities for change control, deviations, training control.
CRB Chair: Chair the Corrective Action Review Board (CRB) meetings.
Supplier Management: Maintain the Approved Supplier List (ASL), approve new suppliers, manage Supplier Corrective Action Reports (SCARs), and approve Quality Assurance Agreements (QAA).
Executive Oversight: Lead management reviews, facilitate and track QMS objectives, and execute quality plans.
Leading 3rd party Audits: Lead ISO 13485, MDR, IVDR, audits
Production & Operations Support
Product Release: Perform Device History Record (DHR) reviews, approve QC tests, and grant final product release.
Facility Control: Oversee equipment maintenance, calibration activities, and environmental monitoring.
Operational Quality: Initiate, investigate, and approve deviations and Non-Conformances (NCs).
Incoming Goods: Oversee purchasing controls and perform incoming inspections for materials.
Cross-Functional Support
Regulatory Affairs: Support technical documentation maintenance, labeling updates, standards monitoring, Post-Market Surveillance (PMS), and adverse event reporting.
Commercial Support: Review customer orders and assist marketing with technical requests as needed. Support and facilitate feedback process.
Culture: Advocate for QMS compliance and build a strong quality culture across the company.
דרישות התפקיד
Technical or scientific degree
Minimum 5 years of quality assurance experience in the medical device industry.
Direct hands-on experience with various EU Classes including IIb or Class III medical devices.
Ability to switch easily between high-level strategy and daily hands-on tasks
Proven track record with EU MDR / IVDR and ISO 13485 audits.
Ability to deliver results. Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers.
Fluent in English.
Advantage: Experienced as consultant
Advantage: experienced with sterilization processes Gamma / EtO