Quality Engineer 3, Central Complaint Vigilance-00000UKJ
Description
Janssen Supply Group, a member of Johnson & Johnson’s family of companies, is recruiting for a Quality Engineer 3 (Central Complaint Vigilance) to be located in Raritan, NJ; Horsham, PA; Beerse, Belgium; or a Janssen site in the EMEA region.
The Quality Engineer 3 is expected to provide scientific/data-driven approaches to support or improve selected quality systems and provide management visibility to product and/or process trends. This role will use statistical techniques, process excellence and quality tools to provide meaningful and detailed analysis and information. This individual generates periodic and ad hoc reports of complaint data to identify trends, improvement opportunities and enlarge management visibility for potential risks related to complaint trends. The Quality Engineer 3 uses complaint data to support the verification of effectiveness of product improvement actions taken upon request. This role supports the processing of complex/non-standard Product Quality Complaints (PQCs). This individual participates in project teams (such as IMT) to develop, maintain, automate, and/or improve compliant vigilance and related/interfacing processes. The Quality Engineer 3 will support the development, deployment, automation, and maintenance of Complaint Report and Analysis processes including and not limited to definitions, automated tools (e.g. Excel/Minitab worksheets). This individual supports the Janssen organization (Janssen sites, Global Medical Safety, Business Quality, LOCs, PDMS, PQM, etc) for complaint reporting and analysis. This role supports Regulatory and Field Actions Committees, Health Authority inspections, and product improvement teams through proactive reporting and analysis of product quality complaint data.
The Quality Engineer 3 prepares routine complaint vigilance and ad hoc reports for management and partners (Janssen Sites, LOCs, GMS, PDMS, PQM, External Business Partners, etc). This individual performs statistical analysis to identify trends/patterns in Complaint data and generates data and analysis to monitor for continuous improvement opportunities. The QE 3 will partner with customers (Manufacturing Sites, Intake Centers, PDMS, Clinical, Global Medical Safety, Marketing, Sales Administration, Brand Protection, ESIQ, etc) to gain knowledge of products and processes. This individual will deploy training on Product Quality Complaint Reporting and Surveillance (including Ad Hoc Reporting, Automated Reporting, etc.) both internally and externally to CCV ensuring full understanding of how to execute transactional tasks AND analysis of data. This individual will identify gaps, redundancies, and inaccuracies to improve the complaint handling process and corresponding data analysis. The QE 3 will review and monitor complaint data across different departments to ensure standard process is followed, data consistency and high data quality for correct decision making. This role compiles product and site-specific complaint trending data and complaint closure metrics as requested. Reports process KPIs. This individual will support internal and external audits and inspections. This role will communicate the value of consistent complaint data to the business and provide guidance and direction on data analysis for complaint management standards and processes.
The QE 3 participates in Issue Management Teams, New Product Introduction Teams to ensure correct data reading is done for PQCs and will solicit customer feedback. The QE 3 executes statistical/data-driven processes and documentation to support controlled risk management and decision making. Ensures appropriate statistical/data-driven decision making is incorporated into processes. This role identifies opportunities for continuous improvement related to trend detection and product improvement. This individual will develop and deliver training for colleagues and partners on data analyses for complaint process and product specific information. The QE 3 will create and maintain WI’s and SOP’s relative to trend detection and statistical evaluation for complaint management processes and develop and deliver training for colleagues and partners on complaint process, reporting tools and product specific information.
Qualifications
A minimum of a Bachelor’s degree in a scientific or technical discipline is required. An advanced degree in Business or a scientific / technical discipline is preferred. A minimum of 2 years of related experience, including Quality Assurance and/or Quality Control, experience working in pharmaceutical, consumer, medical device or other related of highly regulated industry, is required. Experience in statistical evaluation using PE tools is required. Knowledge of manufacturing processes and complaint vigilance global regulatory requirements, including 21CFR and ICH Q10 and CFR 820.198, is required. ASQ Quality Engineer certification, Process Excellence Certification (Yellow Belt / Green Belt), and/or PMP certification preferred.
Strong communication skills in English, organizational and project management skills will be needed. Very strong statistical skills and the ability to analyze data and provide consolidated data to management is required. Strong interdependent partnering skills, interpersonal communication, influencing skills without direct line authority will be needed. The ability to work independently in a global environment/virtual team is a must. The ability to support technical teams toward business goals and to balance competing priorities is required. The ability to engage and align with other diverse and dispersed organizations and functions and support an organization through continuous improvement and change is a plus. Competency in understanding system functionality in relation to process requirements is required.
The ability to travel internationally as needed is required up to 10% of the time. The ability to work outside of normal working hours when needed is required.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:Europe/Middle East/Africa, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality (Eng)
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