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 wh

📌 Sr Engineer Design Quality Thiruvananthapuram
🏢 Artech
📍 Thiruvananthapuram