Overview
Quality Engineer Jobs in Kollam, India at Dräger
Purpose
of Function
This position is required for meeting the
regulatory compliance
& quality requirement of Safety India products.
The position needs to support in product quality of the safety products.
Tasks and Responsibilities
Quality
– Assists in setting up required processes and testing facilities.
Provide support in selection / design of test equipment’s with relevant internal / external
stake holders.
Review and approve product labeling.
Provide support in preparing technical files.
Assists to support domestic and international products registrations by obtaining documentation for other certifications as required
Helps to provide RA product registration/approval/clearance information to help expedite product shipments through import/export requirements as required.
Assists with product registration requirements with an emphasis on Industrial & Mining segments by helping to
– Provide regulatory support and guidance to assigned product teams
Assemble documentation required for annual renewals of establishment registrations, device listings and licenses
Determine regulatory pathway and provides complete global regulatory assessment of product changes, including submission of product registrations.
Provide regulatory support for registrations and requests for documentation and support for registration of portfolio products.
Maintain knowledge and application skills of submission tools, internal databases, and codes within the scope of regulatory affairs.
Performs other duties as needed and assigned.
Ensure the processes and quality of the final products in Safety Devices.
Record & Handle customer complaints & claims (Failure on Arrival & Warranty),
Perform RCA & CAPA
Develop and monitor the traceability and control of vendor supplied inventory.
Education:
Engineering Degree / Diploma in Instrumentation/ Electrical/ Electronics/ Mechanical
Related
Experience:
Around 3-5 years of experience in Quality / Regulatory function of manufacturing.
Skills, Special Competencies, or
Certifications:
Regulatory Affairs Certification (RAC) a plus
Knowledge of Indian and International regulatory requirements for Explosion proof, intrinsically safe devices & cylinder, valves certification
Record of supporting project teams a plus
Good Microsoft application skills
Excellent written and oral
communication skills
Knowledge of current ISO 9001, IECEx, ATEx, PESO, DGMS, BIS, IEC
60079, EN & IS standards related to cylinders / valve etc.
Work in safety device industry would be desirable with knowledge of Gas Groups Areas and zone in Explosive atmospheres.
General Competencies
– Good
communication skills
Logical & Rational
Tactful
Result oriented
Attention to details
Title: Quality Engineer
Company: Dräger
Location: Kollam, India
Category: Engineering, Quality Assurance – QA/QC
