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Senior Product Assurance Engineer
2 weeks ago
Job Title: Medical Devices Expert
Job Description:
- This is a senior-level position responsible for assessing and auditing medical devices to ensure compliance with relevant regulations and industry standards.
- The ideal candidate will have a minimum of 10 years of professional experience in the medical devices industry, with a strong background in quality management and regulatory affairs.
- They should have excellent knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745, as well as experience with risk management and sterilization processes.
- Strong communication and teamwork skills are essential for this role, as the successful candidate will work closely with a team of assessors/auditors.
Key Responsibilities:
- Conduct thorough assessments and audits of medical devices to ensure compliance with regulations and industry standards.
- Develop and implement quality management systems to ensure adherence to regulatory requirements.
- Collaborate with cross-functional teams to identify and mitigate risks associated with medical device development and manufacturing.
- Provide expert advice and guidance on regulatory matters related to medical devices.
Requirements:
- Minimum 10 years of professional experience in the medical devices industry.
- Excellent knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- Experience with risk management and sterilization processes.
- Strong communication and teamwork skills.
