Senior Quality Engineer
We are seeking a highly skilled Senior Quality Engineer with expertise in Operations Quality and New Product Introduction (NPI). This role requires a quality-centric mindset and the ability to manage complex compliance requirements across multiple external vendors.
* Serve as the core contact for Contract Manufacturers, assessing their processes to ensure adherence to quality controls.
----------------------------------- Job Requirements:
A high degree of autonomy is required. The ideal candidate will have deep knowledge of FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and ISO 14971 (Risk Management) standards. The following skills are essential:
1. Quality management system design and implementation,
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