GSC Quality Systems Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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JOB SUMMARY

You will be reporting to the GSC Quality Systems & Compliance Leader where your primary purpose is to:

• Support the execution of the DePuy Irelands Quality Management System Processes

• Deliver support to GSC projects from a quality point of view.

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

DUTIES & RESPONSIBILITIES

• In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• 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/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.

• Understands 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.

• Supports the assigned processes during internal and external audits.

• Acts as Stop Shipment Coordinator for Joint Reconstruction QA MAKE organization

• Responds to and drive/ participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions

• Keeps up to date with all new legislation and regulation standards for all countries and ensure compliance to any changes to these across the facility.

• Represents the processes 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

• All employees are responsible for minimizing both the environmental and Health and Safety effects of the work they perform.

• Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• A third level qualification and three or more years of related experience in a regulated industry environment

• Being proficient in applicable GMP/QSR regulations for medical devices

• Planning and organizing skills

• High level of attention to detail

• Excellent PC interpersonal and influencing skill

Desirable:

• In- depth knowledge of Quality Systems

• Significant FR and BR audit experience

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS

• 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.

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