Manufacturing Engineer

3 days ago


North Haven, United States Sira Consulting, an Inc 5000 company Full time

Responsibilities:

- Develop and execute validation and verification protocols (IQ, OQ, PQ) to ensure processes and products meet specified requirements.

- Prepare and maintain documentation required for regulatory submissions and audits, such as Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).

Experience:

- Medical device industry experience

- Minimum 2 years of experience in Project management

- Strong communication skills

- Strong problem-solving skills

- Familiarity with software tools like Microsoft Office Suite

Qualification:

• BE/BS - Mechanical Engineering



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