Operations Quality Manager

Reposted Yesterday
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Caesarea, Kayseri, TUR
Hybrid
Mid level
Healthtech
The Role
The Operations Quality Manager will lead the quality team, manage compliance and risk management, support audits, and enhance supplier quality across operational processes in a global medical device company.
Summary Generated by Built In
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

Requirements
  • 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.

 

Skills Required

  • Previous experience in management (+3 team members)
  • 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
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The Company
HQ: Caesarea
621 Employees
Year Founded: 1999

What We Do

You already know we create amazing technology that helps millions around the world to live better, more confident lives. You also know that we are at the top of the medical aesthetic market. But we’re here to tell you we are way more than that. We realized that in the modern life, a better way to make innovative technology, is understanding what our partners and their patients really want. To put people and their needs first. So we became better at listening and translating the true needs of your patients into outstanding and cutting-edge technology. We are transforming together. With you. This is what we been doing for the last 20 years. This is what got us to be a leading player in the medical aesthetics field. We take pride being number 1 in China and number 3 globally, and we owe this accomplishment to our people, our partners and our daring spirit. We infuse this spirit in everything we do and we invite you to join us. Whatever comes next we are there. Alma Lasers is a global innovator of laser, light-based, radiofrequency and ultrasound solutions for the aesthetic and surgical markets. Alma Lasers has been at the forefront of multi-technology systems, revolutionizing existing treatment methods and working to serve the varied and growing needs of both patients and practitioners around the world. With offices, R&D and manufacturing facilities on three continents and distributors around the world, Alma's mission is to provide modular, cost-effective and high-performance systems based on the very latest clinical research and cutting-edge technology. We enable practitioners to offer safe, effective and profitable aesthetic and surgical treatments to their patients, while allowing patients to benefit from the capabilities of state-of-the-art, clinically proven technologies and methods.

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