
Senior Quality Assurance Manager
6 hours ago
We are seeking a highly experienced Medical Device Engineer to lead the development and implementation of quality management systems.
The ideal candidate will have a strong background in medical devices and quality assurance, with expertise in regulatory frameworks, risk management, and sterilization processes.
The successful candidate will work collaboratively with cross-functional teams to drive process improvements and ensure effective implementation of new technologies.
- Minimum 10 years of professional experience in healthcare products or related activities.
- At least 5 years of relevant professional experience in quality assurance.
Responsibilities:
- Assess and audit medical devices to ensure compliance with regulatory requirements.
- Develop and implement quality management systems to ensure the highest standards of quality.
- Collaborate with cross-functional teams to drive process improvements and ensure effective implementation of new technologies.
Requirements:
- Excellent knowledge of regulatory frameworks, including ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- Experience with risk management, non-active devices, and sterilization processes.
- Strong communication and collaboration skills.
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