Quality Engineer II
3 days ago
I am partnering with an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease (ICAD) are looking tohire a Quality Engineer II as they expand operations. The Role: This position requires experienced and proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial. Development and supporting Quality Management System (QMS) activities, batch release, internal audits, and supplier management. Responsibilities: Responsible for compliance with Policies and Procedures and applicable National and International Regulations. Leads compliance and improvement activities associated with thequality system (e.g. CAPA, audit programs, personnel training). Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required. Provide expertise in the areas of quality assurance, controls and systems to support and develop the QMS. Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements. Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics. Provide ongoing support to the internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial. Gather and analyse data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations and internal requirements Prepare and maintain detailed records of inspections, testing, and non-conformance reports. Collect, analyse, and report key data related to product testing, supplier performance, and internal quality metrics. Use data-driven insights to drive continuous improvement initiatives, ensuring optimal product quality and process efficiency. Develop test protocols or reports to support the design validations and verification activities. Support the quality control activities, relating to lot release of finished devices, received products or other QC activities. Review and approval of changes to product, processes for existing medical device products are conducted in compliance with global regulations and internal procedures. Requirements: A degree in quality engineering, life science or related field. 3-5 years experience at a quality assurance role in the medical device sector essential, preferably in a FDA/MDR regulated environment. Quality certification and lead Auditor certification an advantage. Knowledge of FDAs 21 CFR Part 820 (Quality System Regulation) and ISO In-depth knowledge of quality engineering principles, methodologies, and tools (e.g., FMEA, SPC, Root Cause Analysis, CAPA, investigations etc.). Experience in the QA activities associated with the design and development of medical devices. Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment. Excellent interpersonal skills and ability to work with people to achieve results. Excellent written and communication skills, fluency in English, attention to detail and strong technical writing skills. Proven record of policy and procedure development. Good judgment/decision making and problem-solving ability, Highly motivated with excellent communication skills and proven ability to work effectively as part of a team an interact professionally with all organizational levels. Proficiency in MS office products. Good business acumen and an enthusiastic self-starter. For more information and a confidential discussion on the role, please contactMichelle Mc Inerney. Skills: Quality Operations Engineer
-
Quality Engineer II
3 days ago
Galway, Ireland Sigmar Recruitment Full timeQuality Engineer II About Your New Employer: Boston Scientific in Galway is at the heart of cutting-edge innovation, transforming lives globally through its life-changing medical devices. As a key player in the MedTech hub of Ireland, the Galway site is renowned for its pioneering work in minimally invasive therapies, boasting a dynamic team that thrives on...
-
▷ (Apply in 3 Minutes) Quality Engineer II
7 days ago
Galway, Ireland Sigmar Recruitment Full timeQuality Engineer II About Your New Employer: Boston Scientific in Galway is at the heart of cutting-edge innovation, transforming lives globally through its life-changing medical devices. As a key player in the MedTech hub of Ireland, the Galway site is renowned for its pioneering work in minimally invasive therapies, boasting a dynamic team that thrives on...
-
▷ [Urgent] Quality Engineer II
1 week ago
Galway, Ireland Collins McNicholas Full timeI am partnering with an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease (ICAD) are looking tohire a Quality Engineer II as they expand operations. The Role: This position requires experienced and proven track record in Quality and Regulatory control...
-
Quality Engineer II- Medical Device Start-up
3 days ago
Galway, Ireland Wallace Myers International Full timeMy client who are an exciting Galway based medical device start-up are seeking a Quality Engineer II to join their team. This position requires 3+ years' experience in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial launch. The role includes development...
-
Galway, Ireland Wallace Myers International Full timeMy client who are an exciting Galway based medical device start-up are seeking a Quality Engineer II to join their team. This position requires 3+ years' experience in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial launch. The role includes development...
-
Manufacturing Engineer II
4 days ago
Galway, Ireland Sigmar Recruitment Full timeManufacturing Engineer II About Your New Employer: Boston Scientific in Galway is at the heart of cutting-edge innovation, transforming lives globally through its life-changing medical devices. As a key player in the MedTech hub of Ireland, the Galway site is renowned for its pioneering work in minimally invasive therapies, boasting a dynamic team that...
-
Manufacturing Engineer II
4 days ago
Galway, Ireland Sigmar Recruitment Full timeManufacturing Engineer II About Your New Employer: Boston Scientific in Galway is at the heart of cutting-edge innovation, transforming lives globally through its life-changing medical devices. As a key player in the MedTech hub of Ireland, the Galway site is renowned for its pioneering work in minimally invasive therapies, boasting a dynamic team that...
-
Manufacturing Engineer II
3 days ago
Galway, Ireland Sigmar Recruitment Full timeManufacturing Engineer II About Your New Employer: Boston Scientific in Galway is at the heart of cutting-edge innovation, transforming lives globally through its life-changing medical devices. As a key player in the MedTech hub of Ireland, the Galway site is renowned for its pioneering work in minimally invasive therapies, boasting a dynamic team that...
-
Design Assurance Engineer II
3 days ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational here in Galway are seeking a Design Assurance Engineer II on a permanent basis to join their growing team. The Role: Fulfil the quality assurance responsibilities of company xxxproduct development and related PTP engineering activities, including: Creating and maintaining a culture of commitment to improving patient safety,...
-
Quality Engineer
1 week ago
Galway, Ireland Cregg Recruitment Full timeJob Title: Quality Engineer II (Design Assurance) Location: Galway-Permanent Industry: Medical Device Company information: Galways world leading medical device manufacturer Role Profile Working under the Principal Engineer this role is ideal for candidates from a strong R&D or MDR background who want to focus on Design Assurance. This role will be 20%...
-
Quality Engineer
3 days ago
Galway, Ireland Cregg Recruitment Full timeJob Title: Quality Engineer II (Design Assurance) Location: Galway-Permanent Industry: Medical Device Company information: Galways world leading medical device manufacturer Role Profile Working under the Principal Engineer this role is ideal for candidates from a strong R&D or MDR background who want to focus on Design Assurance. This role will be 20%...
-
Product Development Engineer II
3 days ago
Galway, Ireland CareerWise Recruitment Full timeProduct Development Engineer II is required by CareerWise Recruitment for our Galway based client. You will participate as a team member in the Product Development process from concept to commercialization of novel Medical Devices. As Product Development Engineer you will act as a technical leader for projects and may be assigned engineers, technician,...
-
Design Assurance Engineer II
2 weeks ago
Galway, Ireland Aerogen Ltd Full timeAbout Aerogen: Headquartered in the vibrant city of Galway, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to...
-
Product Development Technician II
4 days ago
Galway, Ireland Life Science Recruitment Ltd Full timeJob title: Product Development Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and...
-
Product Development Technician II
3 days ago
Galway, Ireland Life Science Recruitment Ltd Full timeJob title: Product Development Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and...
-
(3 Days Left) Design Assurance Engineer II
2 weeks ago
Galway, Ireland Collins McNicholas Full timeOur client a major multinational here in Galway are seeking a Design Assurance Engineer II on a permanent basis to join their growing team. The Role: Fulfil the quality assurance responsibilities of company xxxproduct development and related PTP engineering activities, including: Creating and maintaining a culture of commitment to improving patient safety,...
-
R&D Engineer II
2 weeks ago
Galway, Ireland Boston Scientific Gruppe Full timeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and...
-
▷ [High Salary] Product Development Engineer II
2 weeks ago
Galway, Ireland CareerWise Recruitment Full timeProduct Development Engineer II is required by CareerWise Recruitment for our Galway based client. You will participate as a team member in the Product Development process from concept to commercialization of novel Medical Devices. As Product Development Engineer you will act as a technical leader for projects and may be assigned engineers, technician,...
-
R&D Technician II
2 weeks ago
Galway, Ireland Life Science Recruitment Ltd Full timeJob title: Product Development Technician II Location: Ballybrit Upper Industrial Estate, Galway Benefits: Top salary, Pension, healthcare, yearly bonus, Hybrid working and the option of a 4 day week. Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and...
-
Quality Engineer II
2 weeks ago
Galway, Ireland Medtronic Vascular Galway UC Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks...
