JOB SUMMARY

This position represents the quality organization as an integral team member on development projects for medical devices. The Design Quality Engineer (QE) ensures compliance to QMS and design control process and procedures and ensure maintenance of Quality Records for the design and development of the products. They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design to manufacturing.

This individual performs routine functions which require application of standard techniques, procedures, and criteria in carrying out a sequence of related engineering tasks. Using prescribed methods, performs specific and limited portions of a broader assignment of an experienced Engineer. Duties are assigned to provide experience and familiarization with Design Control regulations and requirements, engineering methods, independent thinking, and company practices and policies.

Experience
- 5 to 12 years of experience within a regulated industry, medical/pharma experience preferred

ESSENTIAL DUTIES




- Supports product design changes and current product development projects, working closely with the development team
- Ensures compliance to QMS and design control processes and procedures
- Reviews and approves documentation that supports product releases
- Interprets, executes and recommends modifications to documents where appropriate.
- Reviews Document changes to verify accuracy and completeness, including Technical Files, clinical data, risk management files, and traceability reports.
- Confirms objective evidence for product development efforts is present and filed within the DHF
- Performs audits of data integrity among Design History Files
- Creates draft risk management documentation for medical device products
- Performs DHF Audits prior to and after Design Transfer
- Analyses data for post market monitoring and risk management
- Interprets, executes, and recommends modifications to documents w

📌 Sr. Engineer- Design Quality (Kozhikode)
🏢 Artech
📍 Kozhikode