Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Quality Systems Specialist
Requisition ID: 1805633764W
DePuy Synthes are now recruiting for a Quality Systems Specialist to join the Quality Team, this opportunity will report directly into the Quality Systems Team Leader., based in our Shingo Prize Winning Manufacturing Facility in Cork.
Live OUR CREDO
Demonstrate and inspire the behaviors that reinforce Our Credo: Credo-based decision making; trusting, collaborative and ethical work environment; highest standards of quality, compliance and accountability
Cultivate external relationships and partnerships: Insight-driven to uncover unmet needs; forge internal collaboration across all levels of the enterprise; develop deep insights into the needs of our patients, customers and markets
Drive innovation; anticipate and shape industry and market changes to advance health care globally: Translate insights into viable products and solutions that create value; Challenge the status-quo; lead and adapt to change; take and manage risks
Create an environment where leadership and talent development is top priority: take ownership for development of self and others; maximize the power of diversity and inclusion; engage in transparent and constructive conversations
Deliver results by inspiring and mobilizing people and teams: empower people to act with speed, agility and accountability; demonstrate a global and enterprise-wide mind-set; balance short and long-term strategic choices.
This position will support the execution of the Site’s Quality Management System Processes and deliver Quality System projects. The successful individual 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.
− 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.
− Where applicable, 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
− 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.
Requirements & Experience
− Third level qualification (preferably Science or an Engineering related discipline) and
− 3 or more years of related experience
− 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.
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.
Depuy (Ireland) Limited (7386)