Lead, Quality Engineering

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Aurangabad, Maharashtra, India

Job Description:

SECTION 1: JOB SUMMARY

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Lead Quality Engineering adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects.

Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods.

He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes

SECTION 2: DUTIES & RESPONSIBILITIES

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Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:


* Ensure compliance with applicable regulations and policies including local and international standards.


* Improve overall efficiency of the processes through use of Process Excellence, Lean principles, and Data analysis.


* Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.


* This individual will function as a quality representative on multi-functional teams in matters relating to Quality Engineering.


* Review/analyze whether current product and processes (including actions or decisions conducted) are complying to MDR 2017, ISO 13485 and other applicable regulations / standards.


* Supports the development of quality strategies related to the transfer of products, materials, and components within J&J or externally.

Supports new product / process / equipment introduction as part of design transfer.


* Support NCR / CAPA/ Complaints/ Internal Audit/ External Audit process.


* Support the Quality Systems used to improve product quality, process and customer satisfaction.


* Make recommendations to management regarding ways to improve Quality and Manufacturing processes in support of current applicable regulations and standards.


* Responsible for communicating business related issues or opportunities to next management level.


* Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environment...