Operations Quality Manager

About the role

Alma, a global leader in medical‑aesthetic technologies, is seeking an Operations Quality Manager to lead its quality function on the production floor. The role will shape quality standards, drive continuous improvement, and ensure compliance with international medical‑device regulations.

Key responsibilities

• Lead, mentor and develop the Operations Quality team.
• Define and enforce quality standards, inspection controls and defect‑prevention methods.
• Manage Material Review Board (MRB) decisions, non‑conformance (NC) and CAPA processes.
• Maintain and improve SOPs, work instructions and operational quality KPIs.
• Act as the primary quality representative during Notified Body, MDSAP, ISO 13485, FDA and customer audits.
• Oversee supplier quality, conduct supplier qualifications and ISO‑based audits, and manage supplier NCs and SCARs.
• Support field‑complaint investigations with rapid root‑cause analysis and corrective actions.
• Lead quality improvement projects aimed at yield enhancement and process stabilization.

Required profile

• Management experience supervising at least three team members.
• Strong decision‑making authority and ability to coach investigators.
• Proven cross‑functional collaboration with Production, Engineering, Supply Chain and Service.
• B.Sc. in Engineering, Quality Engineering, Materials, Biotechnology or a related technical field.
• Hands‑on experience with ISO 13485, MDSAP, FDA QSR, MDR and internal auditing.
• Expertise in NC/CAPA methodologies, MRB processes and supplier quality management.
• Familiarity with risk tools such as pFMEA, control plans and hazard analysis.
• Experience supporting external audits in mid‑size manufacturing sites.

Required skills

• ISO 13485 compliance
• MDSAP
• FDA QSR
• Medical Device Regulation (MDR)
• NC/CAPA management
• Material Review Board (MRB) processes
• pFMEA and risk assessments
• Control plans and hazard analysis
• Internal auditing
• Root‑cause analysis
• CAPA and risk management
• Supplier quality management and supplier audits
• Operational quality KPIs