Mgr 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:
People Leader

All Job Posting Locations:
Raynham, Massachusetts, United States of America, Ringaskiddy, Cork, Ireland

Job Description:

SECTION 1: JOB SUMMARY

Under the direction of the Director of Quality Projects and with the objective of maintaining high quality standards for the product manufacturing process and in compliance with regulatory requirements, provides leadership, technical support and direction to Plant Operations, Technical Operations and Quality Assurance.

Directly supervises Quality Engineers (different levels/pay grades), Quality Team Leaders, Quality Technicians and/or non-exempts associates in day to day activities supporting manufacturing transfers, operator certification program, incoming and finished goods inspections; all in accordance with applicable regulations.  Provide support and expertise on problem solving, process improvements and in the usage of quality tools. 

SECTION 2: DUTIES & RESPONSIBILITIES

Under the direction of the Director of Quality Projects and in alignment with all federal, state, and local laws and Johnson & Johnson corporate guidelines, your responsibilities will include:

Equipment and Process Transfer & Qualification


* Lead Quality Project planning, including development and execution of Transfer Quality Plan


* Support Regulatory submissions and inspections as required


* Support planning & execution of equipment qualification activities


* Conduct and/or participate in troubleshooting and/or deviation investigation efforts during project execution


* Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard.

Metrology / Inspection


* Lead inspection planning activities to ensure all Critical to Quality (CtQ) features are verified with appropriate, qualified inspection and test methods.


* Review/analyze the effectiveness of current metrology equipment / techniques.


* Conduct technical benchmarking of new technology to develop more effective methods for improving quality impacted by metrology.


* Develop, interpret and implement appropriate process inspection and control methods consistent with the level of process/product risk


* Supports cro...