Medical Device Assessment Specialist

2 days ago

Gandhinagar, Gujarat, India beBeeSenior Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

Job Opportunities

">Job Opportunity: Senior Medical Device Engineer

We are seeking a senior medical device engineer to join our team of experts in assessing and auditing medical devices.

Key Responsibilities:

  • 10 years of professional experience in relevant healthcare products or related activities, such as research and development, manufacturing, quality management, and regulatory affairs.
  • 5+ years of experience in quality management is essential.

Requirements:

  • Good knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their application.
  • Experience with Risk Management EN ISO 14971.
  • Solid knowledge of non-active devices and sterilization processes.
  • Ability to work actively with a team of assessors/auditors.

Job Description Overview">

This role involves assessing and auditing medical devices for compliance with international standards. The successful candidate will have a strong background in quality management and be able to communicate effectively with colleagues and stakeholders.

What You'll Do">

The key responsibilities of this role include:

  1. Conducting audits of medical devices to ensure compliance with industry regulations.
  2. Developing and implementing quality management systems.
  3. Collaborating with cross-functional teams to identify and address quality issues.
  4. Providing training and support to colleagues on quality management best practices.

What We're Looking For">

To be successful in this role, you will need:

  • A bachelor's degree in a relevant field, such as engineering or life sciences.
  • At least 10 years of experience in quality management, including experience with auditing and quality system implementation.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

Benefits">

This role offers a competitive salary and benefits package, including:

  • Opportunities for professional development and growth.
  • A collaborative and dynamic work environment.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.

How to Apply">

If you are a motivated and experienced quality professional looking for a new challenge, please submit your resume and cover letter for consideration.

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