Johnson & Johnson Careers
Quality Systems Specialist
Requisition ID: 1905710204W
Quality Systems Specialist
This position will support the execution of the Site’s Quality Management System Processes and deliver Quality System projects. This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements. This role will involve liaising with the Franchise/Sector teams on driving improvement and streamlining of the assigned processes.
List main areas of responsibility:
− Drives compliant execution of the following for their assigned processes and projects
− Manages specified quality system processes.
− Works directly with various customers of the quality system processes to ensure compliance to site/sector/enterprise /franchise/regulatory requirements
− Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner
− Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.
− Understand and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes
− Responsible for identifying and communicating the need for process improvement opportunities to responsible management.
− Identifies personnel that require training on the relevant processes and rolls out training as required.
− Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes. Lead and drive improvements as required
− Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc.
− Support the assigned processes during internal and external audits.
− Systems SME for Internal and External Audits
− Conducts internal audits to ensure compliance to regulatory and customer requirements.
− Responds to and drive/ participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions
− Represents the processes and systems as required at cross-site meetings.
− Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff.
− Responsible for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 as applicable, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company's products including medical devices and combination products.
Additional Responsibilities of Senior Quality Systems Specialist:
− In addition to the above duties the Senior Quality Systems Specialist role also encompasses responsibility of supporting the Quality Systems Manager in the planning and directing of overall Quality System activities.
− Provides continuous support and mentoring to Quality Systems Specialists and Department members.
Education and Experience Required for Role
− At a minimum a Diploma in a Quality, Science or Engineering discipline and 3 or more years of related experience
− Additional Essential Requirements for a Senior Quality System Specialist:
− At a minimum a Diploma in a Quality, Science or Engineering discipline and 5 or more years of related experience
Additional Essential Requirements for Senior Quality Systems Specialist role:
− Experienced SME for FDA and other regulatory authority audits.
− Proven leadership skills
− Successful Completion of Global Projects
Desirable (for both roles):
− Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems
− Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met.
− Demonstrate excellent communication skills (verbal and written) with all levels within the organization, clients and regulatory auditors
− Must show innovative development techniques and strategic thinking abilities
− Demonstrated success in managing multiple projects
− Ability to develop and give presentations on technical and regulatory topics.
− Ability to work on own initiative and a high level of attention to detail
− Ability to train/mentor associates
− Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues.
− Ability to read, analyze, and interpret complex technical documents and manuals
− Ability to define problems, collects data, establish facts, and draw valid conclusions.
Johnson & Johnson Vision Care (Ireland) Limited (8182)