Operations Quality Manager

Description:

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide.

Operations Quality Leadership

• Lead, mentor, and professionally develop the Operations Quality Team.
• Set quality standards, inspection controls, and defect‑prevention methodologies on the production floor.

MRB, NC & CAPA Management

• Lead MRB decision-making and material disposition.
• Own NC/CAPA processes: investigation quality, root‑cause analysis, corrective & preventive action closure.

Quality Systems & Compliance

• Maintain and improve SOPs, work instructions, and quality procedures related to operations.
• Own risk assessments (pFMEA), risk surveys, and operational quality KPIs.

Support for External Audits

• Act as a key operational quality representative during Notified Body, MDSAP, ISO 13485, FDA, and customer audits.
• Ensure operational readiness: documentation integrity, calibration status, inspection records, training, material traceability, and MRB completeness.
• Drive audit response actions, containment, and long-term corrective actions in coordination with RA/QA.

Supplier Quality & Supplier Audits

• Lead supplier quality oversight with Supply Chain.
• Conduct supplier qualification and performance audits (ISO 9001/13485-based).
• Manage supplier NCs, SCARs, incoming defects, and continuous improvement activities.
• Align incoming inspection plans with supplier capability and risk level.

Complaint Investigation Support

• Partner with Global Service for field complaint investigations, ensuring fast and accurate operational root‑cause analysis and corrective actions.

Operational Excellence & Projects

Lead quality improvement initiatives, yield enhancement, process stabilization, etc

• Previous experience in management (+3 team members)
• Confident decision‑maker; high professional authority, Coachable
• Ability to coach investigators and elevate quality discipline across Operations.
• Strong cross‑functional collaboration: Production, Engineering, Supply Chain, Service.
• B.Sc. in Engineering, Quality Engineering, Materials, Biotechnology, or equivalent technical field
•  ISO 13485 & MDSA
• Internal Auditor
• Root‑Cause Analysis methodologies
• CAPA & risk management
• Supplier/Lead Auditor certification

Experience working with:

• Middle size manufacturing sites including multiple cross functions
• Global medical device companies
• ISO 13485, FDA QSR, MDSAP, MDR
• NC/CAPA methodologies
• MRB processes
• Supplier quality management
• Risk tools: pFMEA, control plans, hazard analysis
• Experience supporting external audits and conducting internal or supplier audits.
• Data-oriented: comfortable with dashboards, trends, and statistical thinking.