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Highly Skilled Senior Device Specialist
2 weeks ago
Our goal is to engage a Senior Device Engineer who will be accountable for evaluating and auditing medical devices to ensure they meet high standards of quality and safety.
We are seeking an experienced professional with at least 10 years of relevant work experience in the healthcare products industry, including research and development, manufacturing, quality management, or regulatory affairs.
This role requires strong knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application as well as expertise in Risk Management EN ISO 14971, sterilization processes, and non-active devices.
The ideal candidate will have excellent communication skills and be able to work collaboratively with a team of assessors/auditors.
Key Responsibilities
- Evaluate and audit medical devices to ensure compliance with regulatory requirements.
- Conduct risk assessments and develop mitigation strategies.
- Collaborate with cross-functional teams to identify and address quality and safety issues.
- Develop and implement process improvements to enhance device safety and quality.
We welcome applications from qualified candidates.
