Quality Assurance Engineer

Join Alma Lasers, a leading global medical device company at the forefront of aesthetics innovation.

We are actively seeking a Quality Assurance Engineer with 3-5 years of experience in the medical device industry. If you have a proven track record of managing QMS in compliance with industry standards and proficiency in FDA CFR, ISO 13485, and 14971, we invite you to submit your application and be part of our dynamic team.

Responsibilities:

• Managing and maintenance of the company QMS in compliance with standards and regulations.
• Support in external/internal/suppliers audits system.
• Leading in CAPAs, NCRs, and ECOs as quality assurance representatives.
• Guiding of production related to QA activities.
• Support Regulation & R&D processes as a quality assurance representative.

Qualifications

• Quality\ Production\ Biomedical\ Mechanical\ Industrial Engineering.
• 3-5 years of experience in quality in the medical device industry.
• Thorough knowledge of applicable regulations and standards (FDA CFR, ISO 13485, 14971) and Professional technical experience.
• Proficient in written and spoken English.
• Familiarity with software tools.
• Qualified as a Lead Auditor (preferred).
• Knowledge of using ERP systems.