Quality Systems Engineer
Found in: beBee jobs IE - 2 weeks ago
We are delighted to introduce a compelling opportunity to join our esteemed client in the medical device industry as a Quality System Engineer. Our client is a leader in the field, dedicated to producing high-quality medical devices and advancing healthcare. If you have a passion for quality assurance, a proven track record of excellence, and a desire to drive innovation, we invite you to explore this role and become a vital part of our growing team.Our client is a well-established and reputable player in the medical device industry. With a commitment to improving healthcare through cutting-edge technology, they have consistently delivered high-quality, life-saving products to patients around the world.
As the Quality System Enginee r, you will play a pivotal role in ensuring the quality and safety of our medical devices.
Responsibilities:
- Representing Quality function in Site Management meetings as required.
- Acting as a delegate for the Quality Lead.
- Leading and implementing significant process improvements, projects and cost saving initiatives using data & quality tools to drive quality decisions. Initiating project plans, identifying resource allocations, performing and guiding technical activities such as risk documentation, procedural updates, test methods, process / software validation that have major importance to the business.
- Initiating, reviewing, approving, and providing guidance on change controls and change control process.
- Performing, analysing and interpreting statistical data using a detailed understanding of statistical tools and methods.
- Leading investigations and providing technical guidance to peers in relation to CAPAs and NC and to address compliance issues and providing guidance to engineering.Leading the implementation of robust solutions.
- Ensuring QMS is implemented and adhered to by completing independent assessment of QMS documentation as required. Independently assess and provide guidance to Quality and Engineering disciplines.
- Provide periodic training for company personnel on the company's Quality System processes and procedures.
- Performing and leading Internal and Supplier Audits.
- Facilitating and participating in external regulatory body audits, e.g. ISO and FDA
- Implementing Key Performance Indicators within the Quality Assurance area to align with site and global quality objectives.
- Complete data analysis for Management Review.
- Co-ordinate collection of data for PMS.
- Actively lead QMS Process Improvement Projects
- Complying with all relevant training required and adhere to relevant associated documentation.
- Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Following strict adherence to the requirements of CGMP.
- Ensuring compliance to quality systems and all applicable regulations/standards, and internal procedures.
Requirements:
- Degree in Engineering or Science related field (minimum level 8)
- Lead Auditor or Internal Auditor certification an advantage.
- 5 years' experience working in a regulated environments, specifically medical device
FULL SPEC ON APPLICATION
If you are interested in learning more about this fantastic opportunity, please contact Cathal Herron:
#J-18808-Ljbffr
-
Quality System Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeQuality Systems EngineerThis role supports the Quality Systems Manager and will include implementing & maintaining the Quality Management System in accordance with applicable standards and regulations.Responsibilities:Be a key driver of cGMP practices within Quality and OperationsBe the primary contact for other departments providing quality oversight to...
-
Quality Systems Associate
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeResponsibilities • Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents. • Administrate documents on the document management system acting as the primary document coordinator. • Provide support to users of the document management system. • Act as the...
-
Quality Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland CPL Healthcare Full timeQuality Engineer Permanent Engineering manufacturing This is a dream job for anyone that has an interest in heavy engineering or Agri related machinery. This is a hidden gem that manufacture and supply with a large global market and the site is commutable from Cavan, Meath and parts of Westmeath.The primary function of the role is to provide Quality...
-
Manager, Quality Engineering
Found in: beBee jobs IE - 3 weeks ago
Dublin, Dublin City, Ireland Edwards Lifesciences Full timeThe primary purpose of this job is to act as the communication cord between the manager and the employees. Oversees quality system metrics and data providing work direction for Quality Engineers and Quality Technicians to support and maintain quality management system, risk management and quality control plans. Responsible and directs activities for one or...
-
Staff Quality Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Stryker Corporation Full timeStaff Quality Engineer - NPI page is loaded Staff Quality Engineer - NPI Apply locations Carrigtwohill, Ireland time type Full time posted on Posted 11 Days Ago job requisition id R513952 Work Flexibility: Hybrid or Onsite Who we want: Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to...
-
Staff Quality Engineer
Found in: beBee jobs IE - 3 weeks ago
Dublin, Dublin City, Ireland Stryker Group Full timeWhy engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly...
-
Manufacturing Systems Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeManufacturing Systems EngineerThe Manufacturing Systems Engineer is to be primarily responsible for the delivery of the approved site programmes relating to manufacturing systems and technology development including, but not limited to, serialisation, automation improvements, sustainability, engineering systems and operations digitalisation and development...
-
Quality Engineer
Found in: beBee jobs IE - 3 weeks ago
Dublin, Dublin City, Ireland Stryker Corporation Full timeProvide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our...
-
Senior Performance Quality Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeSenior Performance Quality Engineer· Dublin – Hybrid· Long Term Contract· Negotiable Day RateGlobal Financial Services / Investment Organisation is looking a Senior Performance Quality Engineer to join their team on a long term rolling contract. The role will be reporting to the Team Lead of the Performance Automation & Testing Team, you will be...
-
QA System and Validation
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager.Position Description:The QA Systems Validation Specialist will be responsible for:• Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
-
Engineer, Quality Assurance Engineering
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Stryker Group Full timeWhy engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly...
-
Staff Quality Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Stryker Group Full timeWhy engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly...
-
Big Data Systems Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Reperio Human Capital Full timeBig Data Systems Engineer Location: Dublin Duration: Initial 12 Month (potential to extend further) A new opportunity has opened up for a Senor Big Data Systems Engineer to join my global client, based in Dublin, Ireland. This is an initial 1 year contract with great potential to extend. My client are looking for a strong data engineer to join the team to...
-
Systems Development Engineer
Found in: beBee jobs IE - 3 weeks ago
Dublin, Dublin City, Ireland Amazon Full timeJob ID: | Amazon Development Centre Ireland Limited If you love infrastructure and automation, we are the team for you AWS CloudWatch is blazing new trails as a pioneer in the cloud Infrastructure Monitoring, Application Monitoring, and Log Analytics space. We are seeking a Systems Development Engineer to join the team to help us with delivery of large...
-
Associate Manager Quality Compliance
Found in: beBee jobs IE - 3 days ago
Dublin, Dublin City, Ireland GrabJobs Full timeJob summaryAssociate Manager Quality Compliance position Facilitating activities and relationships regarding External Manufacturing change controls Lead and manage direct reports, work to develop and oversee their performance and growth Job seniority: mid-to-senior level Responsibilities Meeting with External Manufacturing department to discuss changes for...
-
Quality Technician
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeOn behalf of our client, we currently have an excellent opportunity for a Quality Technician to join a growing Medical Technology company. Dublin location, predominately site based with some hybrid.The Quality Technician will work closely with colleagues to support the following activities:· Creation, review, and approval of QMS documentation.· Process and...
-
Pharmacovigilance and Clinical Quality Specialist
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeOn behalf of my client, a global pharmaceutical company, we are working with them on a new role for a Pharmacovigilance and Clinical Quality Specialist. This is a full-time permanent role based in Dublin. The Role & Responsibilities: The main purpose of this cross functional position is coordinating and leading a variety of: Pharmacovigilance system quality...
-
QC Digital System Specialist
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeCpl in partnership with our client Pfizer are seeking a QC Digital System Specialist to join the team for an 11 month fixed term contingent contract at their state of the art plant in Grange Castle, Dublin. Role Description:The QC Laboratory Digital Systems Specialist will drive modernization and robustness initiatives at the Grange Castle site by working...
-
Bray Automation Control Systems Engineer II
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Jabil Circuit Full timeJOB SUMMARY The purpose of the job is to support the delivery and maintenance of automated assembly lines by working across the programs and manufacturing engineering teams. The automation engineer works with the programs team to support the introduction of new assembly lines by generating/reviewing specification and design documentation. The...
-
Systems Field Service Engineer
Found in: beBee jobs IE - 2 weeks ago
Dublin, Dublin City, Ireland Ebara PM Full timeWorking at EBARA Precision Machinery Europe (EPME) means you are connected to the top 20 micro-chip manufacturers. The semiconductor manufacturing market continues to grow. Our customers are using high-precision manufacturing technologies to provide; IoT, cloud servers, silicon technology, 5G, sensors for autonomous vehicles, flat panel displays,...