Search Results: 92 vacancies
...Senior Quality Engineer with ISO 13485 and FDA QSR expertise market-leading M edical Devices company in Galway. Working with a collaborative team, you will Lead Quality Engineering support of the manufacturing process & drive process continuous improvements.
RESPONSIBILITIES...
...a related discipline is a necessary requirement for this position
* 2-3 years relevant experience
Experience Required
* Maintain ISO 14001 and ISO 45001 Certification.
* Liaise with Managers /Ensure employees are trained to a defined competency standard with all applicable...
Sligo, Co. Sligo
15 days ago
£51.6k - £64.5k per annum
...programmes in conjunction with the Validation Management.
* Conduct validation activities in compliance with US and EU regulations, ISO standards, Corporate Policies and EHS requirements.
* Support and develop direct reports to ensure their training and development needs...
County Galway
13 days ago
...product.
Demonstrate and actively promote highest level of professional QA Engineering discipline and rigor.
Be a leader in QSR, ISO / MDD standards within your group, be constantly aware of best industry practices.
Have significant expertise in validation engineering...
...knowledge of EHS requirements within Irish construction sites
Excellent IT skills and knowledge with quality and safety management systems (ISO)
Strong people management and leadership skills
Excellent communication skills
HVAC or mechanical experience an advantage...
...using statistical analysis and experimental design for medical device testing.
Knowledge of regulatory standards such as 21CFR820, ISO 13485, and familiarity with MDR.
Benefits:
Competitive salary and benefits package.
Opportunity to work in a cutting-edge field...
...Degree in a Science or Engineering discipline
~3-5 Years’ experience working in a medical device environment
~ Strong knowledge of ISO 13485, FDA regulations 21CFR 820
~ Strong knowledge of MDR & FDA product submission requirement
~ Strong understanding of the...
...appropriate safety systems and safety architecture.
Safety control system reviews and calculations to ensure compliance to CE standards (e.g. ISO 13849).
Compilation of CE marking technical file documentation.
Ensuring equipment meets appropriate safety standards and...
...engineering projects. Attend design meetings and submit planning documentation. All work will be carried out in accordance with the company's ISO procedures.
What you'll need to succeed
You will have a Degree in Structural Engineering or relevant discipline. 2–5 years...
...investigation for areas under their control.
-Continually seeks to drive improvements in product and process quality.
-Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the...
...Role:
As the QA Engineer you will have strong knowledge of Quality system processes for medical devices with the aim of gaining ISO 13485 certification . You will support the development of the quality system and ensure ongoing medical device quality control for the...
...limited to :
Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Participation in the new product introductions programmes to ensure that they are effectively introduced...
...Safety
To take responsibility for Health and Safety Procedures on site on behalf of the company
To ensure compliance with company ISO quality systems and procedures
To carry out Risk Assessments in accordance with above procedures
To ensure that all safety data...
...Dynamic, motivated, results-oriented approach to work.
Excellent communication, planning, and organizational skills.
Knowledge of ISO & FDA compliance.
Competencies
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
ABOUT TE CONNECTIVITY
TE...
...quality, customer satisfaction, and manufacturing efficiency through collaborative programs.
Ensure all project management adheres to ISO and FDA regulatory standards.
Requirements:
Bachelor’s degree in Engineering or Science, with a Master’s degree preferred.
A...
...and procedures.
Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
Remains current with regulations and standards.
Support the continuous improvement of quality...
...all audit schedules
Liaise with Auditor regarding year end accounts for SAS and FGP
Assist with Management Meeting Minutes and PSA/ISO Audits where necessary
Complete and Submit Bi monthly VAT returns
Credit Control
Post all deposits to the Factoring bank...
€35k - €45k per annum
...archived or disposed of.
Ensure that all quality-related documents adhere to relevant regulatory requirements, such as FDA regulations, ISO standards, and industry best practices.
Provide support for the development, implementation, and maintenance of the organization's...
...resources in a safe environment and be responsible for Health and Safety goals.
Perform and support internal and external audits to ISO and FDA requirements.
Perform an active role in further development and continuous improvement of the Quality Management system....
..., manage, and investigate complaints including co-ordinating RMA’s as required and providing response to customer
• Be a leader in ISO standards within your group, be constantly aware of best industry practices.What do we offer?
• Market-competitive total reward: flexible...
