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Search Results: 103 vacancies
- ...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
- ...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
- ...Quantity Surveyor Main Duties and Responsibilities: Ensure compliance with Kilcawley Construction Quality Management System & ISO 9001 Ensure Compliance with Kilcawley Construction Environmental & Safety Management System & OHSAS 18001 and ISO 14001 As...SuggestedPermanent employmentContract workFor subcontractorInterim roleWork at office
€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...SuggestedPermanent employmentFor contractorsFor subcontractorWork at office€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...SuggestedPermanent employmentSummer workWork at officeHybrid work- ...# 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.,...Suggested
- ...Customer facing activity. Ensure that all Product and Process areas of responsibility meet the required criteria and standards, such as ISO standards and Customer audits. Conduct and oversee Weekly Product audits and special process audits by value stream. Identify...Suggested
- ...interaction. ~ Strong team member with the ability to identify and drive efficiency improvements. Occasional work may be done in an ISO Class 7 cleanroom environment. Powder free gloves, face masks, hairnets, gowns, and shoe covers must be worn. Because smokers continue...SuggestedCasual workWorldwide
- ...experience in medical device R&D ~ Strong design, problem-solving, and communication skills ~ Experience with regulated environments (e.g. ISO 13485, FDA) ~ Project management experience is a plus For more information and a confidential discussion on the role please...SuggestedContract workFixed term contract
- ...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...SuggestedContract workRemote workShift workWorking Monday to Friday
- ...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...SuggestedRemote workHybrid work
- ...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...SuggestedContract workFlexible hours
- ...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
- ...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
- ...skills (e.g., PowerShell, VBScript, batch files, etc.). Physical Demands This role will require occasional work may be done in an ISO Class 7 cleanroom environment. Please be aware that when entering this environment, you will be required to wear powder free gloves,...Full timeCasual workWork at officeRemote work
- ...Preferred Qualifications RJG Master Molder I & II Certification Experience in medical device manufacturing Familiarity with FDA/ISO regulations ASQ Green/Black Belt Certification Hands-on experience in mold making and plastic part design Why Join...Full timeWorldwide
- ...occasional travel across the UK and Europe for inspections, audits, and compliance oversight. You will play a key part in upholding our ISO 9001, 14001, and 45001 certifications and embedding a culture of continuous improvement and compliance throughout the business....Full timeFor subcontractor