Senior Quality Engineer

Required:

• B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Supplier quality.
• Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
• Ability to effectively communicate information to team members, leaders, management, and suppliers.
• Experience supporting third-party inspection (FDA, Notified Body etc.) within the medical device industry.
• Proficient in MS Office Suite (including Word, Excel, Power Point etc).
• Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).

Preferred:

• Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive.
• Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
• Preferred German Language exposure

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• ISO 13485 Lead Auditor certification or equivalent