Get new jobs by email
- ...Senior Quality Engineer with ith ISO 13485 and FDA QSR expertise required by leading Galway Medical Devices company to support manufacturing processes and drive continuous improvements . This role offers the opportunity to work in a collaborative, high-performing environment...SuggestedFull time
- ...engineering to define requirements (URS, FRS, SRS) and architectural decisions. Ensure design controls and traceability meet IEC 62304 , ISO 14971and ISO 13485 standards. Maintain rigorous documentation to support product quality and regulatory submission. Delivery &...SuggestedFull timeHybrid workFlexible hours
- ...Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169. Support development and evolution of Design Control, Risk Management, and...Suggested
Life Science Recruitment
Galway2 days ago - ...Quality Engineering functions at the Galway site. This role ensures compliance with global regulatory requirements including 21 CFR 820, ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R Sch.3, MDR, and other applicable standards. The position oversees quality systems,...Suggested
TE Connectivity Corporation
Galway1 day ago - ...qualification in Health and Safety. ~3 years successful postgraduate experience in Project HSE Management. ~ Thorough knowledge of ISO: 45001 and ISO: 14001 standards. ~ Working towards graduate membership of IOSH. ~ Ability to deliver internal Health and Safety management...SuggestedFor subcontractor
BAM Group
Galway3 days ago - ...sciences or laboratory services industry. Strong understanding of lab procedures, equipment, and industry regulations. Familiarity with ISO, OSHA, and FDA standards is preferred. Demonstrated experience in creating, delivering, and evaluating training programs, with the...Suggested
Collins McNicholas Recruitment
Galway1 day ago - ...goals. Build and manage a high-performing R&D and engineering team. Ensure full compliance with medical device regulations (e.g. ISO 13485, IEC 62304, FDA 21 CFR Part 820, EU MDR). Oversee system architecture, risk management, design controls, and quality assurance...SuggestedPermanent employmentFull timeHybrid work
Wallace Myers International
Galway4 days ago - ...qualification in Health and Safety. ~3 years successful postgraduate experience in Project HSE Management. ~ Thorough knowledge of ISO: 45001 and ISO: 14001 standards. ~ Working towards graduate membership of IOSH. ~ Ability to deliver internal Health and Safety management...SuggestedFor subcontractor
BAM Group
Galway2 days ago - ...and findings Communicate audit findings by preparing a final report discussing findings with auditees Comply with legal/licensing/ISO requirements, enforcing adherence to requirements, advising management on needed actions Prepare special audit and control reports...Suggested
PlaceMe Recruitment
Galway1 day ago £25.9k - £30.21k per annum
...offs Track all documentation from initial submission to final approval Identify and resolve document errors and maintain compliance with ISO and BIM systems The Person: Experience in document control, administration, or data management Organised, meticulous, and proactive...SuggestedPermanent employmentFor contractorsFor subcontractorLong term contractGalway10 days ago- ...mitigating risk exposure. Conducting periodic audits on transactions submitted by brokers. Complying with laws, regulations, and ISO requirements. Supporting Import and Export Licences applications when necessary. YourExperienceand Background include: ~ Capable...SuggestedPart timeJob sharingFlexible hours
ASSA ABLOY Global Solutions
Galway15 hours ago - ...Lead technical discussions with suppliers and contribute to customer meetings. Document work comprehensively, including generating ISO component drawings and reporting progress. Act as technical expert/owner for one or more optical subsystems through the full product...SuggestedFull timeFlexible hours
- ...managing and continuously improving the Quality Management System (QMS). You will ensure that products meet rigorous standards, including ISO 13485, FDA QSR and MDSAP. Leading a team of System Engineers and Data Systems Analysts, you’ll support compliance, audits and help...SuggestedFull time
- ...Apply quality engineering expertise across the Quality Management System (QMS). Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820. Assist with design assurance activities, including design controls, verification, and validation....SuggestedPermanent employmentFull timeImmediate start
- ...multiple disciplines. ~ Strong technical leadership with experience in automated and lean manufacturing environments. ~ Expertise in ISO 13485 , FDA QSR , EU Medical Device Regulation and MDSAP . ~ Experience with eQMS and MES systems. ~ Professional...SuggestedFull timeLong term contract
€40k - €50k per annum
...networks, flood assessment and mitigation measures and traffic assessments. Your work will be carried out in accordance with the company ISO procedures. A solid understanding of the engineering principles behind drainage, water, roads and traffic system design. IT...Permanent employmentSummer workWork at officeHybrid work€45k - €65k per annum
...end of the project. Liaising with management in relation to Training requirements Facilitating toolbox talks. Assisting with ISO audit compliance, and H & S related assistance when required by the H&S Manager and Director. Liaising with main contractors and site...Permanent employmentFor contractorsFor subcontractorWork at office- ...# Good understanding of lean principles and methodology (e.g., DMAIC, Kaizen, Value Stream Mapping). # Excellent understanding of ISO 13485 and FDA processes. # Experience with statistical techniques (DOE, Six Sigma). # Proficiency with engineering software (e.g.,...
Life Science Recruitment
Galway1 day ago - ...Minimum of 5 years' experience in a Quality Assurance or Design Assurance role within the medical device industry. In-depth knowledge of ISO 13485, 21 CFR Part 820, and other applicable global medical device regulations and standards. Demonstrated experience with design...Fixed term contract
Collins McNicholas Recruitment
Galway4 days ago - ...Responsibilities Quality Assurance Own, maintain, and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 , FDA 21 CFR Part 820 , EU MDR , and other relevant standards. Lead internal and external audits, including regulatory...Remote workHybrid work
Wallace Myers International
Galway2 days ago - ...Qualification (PQ) protocols. - Develop PFMEA and Control plans as parts to meet validation or PPAP requirements - Ensure compliance with ISO 13485 standards and support audits and inspections. - Collaborate with cross-functional teams to implement quality improvements and...Permanent employmentFull time
Dawnlough Ltd.
Galway2 days ago - ...high-growth, entrepreneurial environment • Ability to travel domestically and internationally ~10% • Experience with 21 CFR 820 and ISO 13485 / 9001 • Strong organizational skills with the ability to manage multiple tasks including management of Business Processes and Projects...Contract workFlexible hours
Uniting Holding
Galway2 days ago - ...Good knowledge of excel and SAP system. • FIFO principles of warehouse is an advantage. • Knowledge of and adherence to Quality/ISO audit requirements. Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment...Contract workRemote workShift workWorking Monday to Friday
- ...Management and deliver projects within agreed timeframes and budgets. Document all aspects of system support including all procedures to ISO standards. Provide innovative inputs to new production lines in the areas of control, data collection, motive power, robotics,...Permanent employmentContract workFor contractorsRemote work
- ...skills. Proven ability to work both independently and as part of a collaborative team. ADVANTAGEOUSl Experience working within ISO 13485 or other quality management systems. Familiarity with imaging systems or camera modules. Understanding of DFM/DFT...Full timeHybrid work
- ...primary commitment to patient safety and product quality. Understand and comply with all regulations governing quality systems (including ISO 17025 for accredited laboratories). Deliver key quality and performance objectives. Conduct testing according to written...
Boston Scientific Gruppe
Galway4 days ago - ...processes of moderate complexity, and drives the team to achieve Quality Goals set by management following industry standards such as ISO, IPC, AS, TL Leads Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium...
Collins McNicholas Recruitment
Galway2 days ago - ...development of medical devices with a track record of successful project delivery. In-depth knowledge of medical device regulations (ISO 13485, FDA, CE Marking) and quality management systems. Proficiency in CAD software (e.g. SolidWorks), finite element analysis, and...
Barrington James Limited
Galway1 day ago - ...compliance with quality and business requirements. Train and mentor staff, as the company scales. Ensure compliance with relevant ISO and FDA regulatory requirements (e.g., ISO 13485, 21 CFR Part 820). Personal Attributes – The Ideal Candidate Is: Creative: A...Contract workFlexible hours
Luminate Medical
Galway1 day ago - ...including but not limited to the Health and Safety Authority) in relation to health, safety and environmental matters. Implement and audit ISO 14001:2004 and OHSAS 18001:2007 standards. Maintain and implement “SafeTcert” accreditation. Carry out site safety audits and...For subcontractorWork from home2 days week
