Search Results: 60 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...
...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...
...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...
...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...
...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...
...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, results-oriented, and adaptable work approach.
Strong communication, planning, and organizational skills.
Understanding of ISO & FDA compliance.
Competencies
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
ABOUT TE CONNECTIVITY
TE...
...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...
€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...
...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...
...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...
...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...
...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...
...to be on call.
Must have good documentation skills and must be computer literate.
Excellent communication, planning and organizational skills.
Knowledge of ISO & FDA compliance.
Competencies
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork...
..., 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...
...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...
Team Horizon
Galway
21 hours ago
...effective and timely closure of Quality System documentation (Audit Actions, SCAR’s, SCN’s, PAN’s, etc.).
Maintain compliance with ISO and FDA Quality System regulations.
The role will also support external audits, internal audits and any relevant Quality/Regulatory...
...that all changes are implemented in compliance with the QMS, (ISO13485 / FDA) and the OH&S, Environmental and Energy Management Systems (ISO 45001, ISO 14001 and ISO 50001) and other regulatory requirements as relevant to the Company.
Contribute to the continual...
...background with new product introduction experience preferred.
Motivated self-starter with decision-making ability.
Knowledge of ISO and FDA compliance, with emphasis on validation.
Proficiency in six sigma and lean manufacturing principles.
Excellent communication...
