Quality Systems Analyst
Location: Cork, Ireland
Duration: 12 months
Hours: 39
Role and responsibilities
This position will support the execution of the Quality Management System Processes and participate in 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.
In accordance with all applicable federal, state and local laws/regulations andCorporate 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
* The execution of the certificate of analysis and sterility process for DePuy Synthes joint recon business units. Including day to day requests and ad-hoc regulatory requests.
* 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 use 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.
* 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
* Support the assigned processes during internal and external audit
* Where applicable, participates in external/ 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
* 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.
* The control, upkeep and distribution of all Quality Documentation including procedures, specifications, records etc. in both hardcopy and softcopy formats.
* Control input to the Windchill PLM System ensuring required reviews and approval of changes, timely.
* Assisting in the Purchase Order raising process for the Quality team.
* Responsible for communicating business related issues or opportunities to next management level
* 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
how to succeed
* Third level qualification (Science or an Engineering related discipline) – or industry experience equivalent
* Planning and organising skills
* Excellent PC, interpersonal and influencing skills
Required knowledge, skills and abilities
* Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems
* Ability to prioritise 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 organisation, clients and regulatory auditors
* Ability to develop and give presentations on relevant topics.
* Ability to work on own initiative and a high level of attention to detail Ability to define problems, collect data, establish facts, and draw valid conclusions
Benefits
This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months.
you are welcome here
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about DePuy Synthes
DePuy Synthes is the orthopaedic and neurological businesses of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare company. At DePuy Synthes we specialise in our innovations in healthcare products, services and programs that make a real difference to millions of people across the world. We specialise in joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, and also the VELYS Digital Surgery portfolio. Contribute to the next healthcare breakthrough with your next project at DePuy Synthes.
https://www.jnjmedtech.com/en-US/companies/depuy-synthes
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, Limited & Umbrella options are available.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.
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