Principal Design Quality Engineer, Clinical
2 months ago
Responsibilities
Assume a Subject Matter Expert (SME) role on Product Development process activities and related workflows in relation to regulatory compliance, provide ‘solution-based’ problem resolution Act as Quality specialist in relation to design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate: ISO 9001; ISO 13485; 21 CFR parts 11 and 820, ISO 62304, ISO 62366, ISO 14971. Mentor to Design Quality Engineers, Clinical on design control requirements and approach Provide interpretation guidance and mentorship on industry best practice deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the quality management system. Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal Waters policies and procedures are met. Provide leadership and direction on all quality activities necessary for the design quality to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance, product performance and registration. Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product development (planning, requirements, architecture, verification/validation including risk management, maintenance, configuration management and problem resolution.
Qualifications
Education
Minimum of a Bachelors Degree required. Chemistry, Medical or Science Graduate education is preferableExperience
Extensive demonstrable experience of leading quality assurance activities supporting product development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820. Extensive demonstrable experience in the application of design controls and risk management including design transfer, process validation and process control plans. Desired – generation of product development collateral for regulatory submissions, IVDR technical files, 510KCompetencies
Strong leadership, coaching and mentoring skills. Strong ability to lead staff dispersed across many different locations and cultures Strong organization/prioritization skills Exceptional interpersonal skills using written and oral communication are required, for example to ensure succinct report generation, effective communication with stakeholders, peer groups etc. across organization. Strong analytical skills with the ability to identify, diagnose, and solve problems with minimal direction and make decisions with confidence-
Senior Design Quality Engineer
1 month ago
Wexford, Ireland Waters Corporation Full timeResponsibilities Participate in new product development projects by providing design quality engineering support for assigned projects. Ensure engineering and scientific analyses are employed and design history files align with company policies and applicable standards and regulations. Key deliverables include but are not limited to performing...
-
Senior Design Quality Engineer
1 month ago
Wexford, Ireland Waters Corporation Full timeOverview Waters are seeking a Senior Design Quality Engineer to join their team on a FTC 12 month contract. This position will be accountable for concurrent quality engineering activities associated with new product development, on-market product design change for instrument hardware and software. Primary responsibility will be to provide design...
-
Principal Project Manager, Clinical
2 months ago
Wexford, Ireland Waters Corporation Full timeOverview Clinical Systems Development is a new team created to develop Waters Clinical and IVD Systems, Hardware and Software. This is a great opportunity to get involved in the growth of this young organisation, with a mission to better meet the unique challenges of our Clinical customers and accelerate the growth of this segment of Waters business. ...
-
Wexford, Ireland Waters Corporation Full timeOverview Key leadership position for Quality, Regulatory and Clinical activities in support of the In Vitro Diagnostic Clinical business. The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business...
-
Wexford, Ireland Waters Corporation Full timeOverview Key leadership position for Quality, Regulatory and Clinical activities in support of the In Vitro Diagnostic Clinical business. The role will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Waters Quality, Regulatory & Clinical Affairs strategy to support Waters business...
-
Wexford, Ireland Waters Corporation Full timeResponsibilities Strategic Activities: Lead the Global Design Quality Assurance, Regulatory & Clinical Affairs functions for Waters Clinical Business Unit, with emphasis on global strategy for in vitro diagnostic clinical business activities. Lead regulatory strategy planning and execution for all key clinical programs globally. Monitor trends...
-
Principal Project Manager, Clinical
2 months ago
Wexford, Ireland Waters Corporation Full timeResponsibilities Working in a self supervisory role to set and establish the direction of Projects. To take full accountability for the completion of those Projects that are on the critical path to the delivery of Waters' Clinical business strategy. To ensure that the projects have routine risk management and mitigation in place in order to ensure...
-
Clinic Manager
5 months ago
Wexford, Ireland B. Braun Medical Ltd Full timeIs it your time to lead, is it your time to join an amazing dynamic team and lead a team of dedicated Healthcare Professionals? Want to know more.... keep reading..... Position: Clinic ManagerLocation: B. Braun Wellstone Renal Care Centre, WexfordReporting to : Renal Business LeadPermanent Position 37.5 hour week - can be done over 4 days on siteRole...
-
Senior Mechanical Design Engineer
2 weeks ago
Wexford Town, Co. Wexford, Ireland Tekpak Automation Ltd Full timeThis is an excellent opportunity for an ambitious Senior Mechanical Design Engineer with proven mechanical design experience to join a leading designer and producer of robotic & packaging solutions. Skills: Getting it Right First Time Mind Set Project Management Experience Continuous Improvement Experience 3D Modelling Design Machine Build Experience...
-
Clinical Nurse Manager
2 weeks ago
Wexford Town, Co. Wexford, Ireland LinkPlus Full timePosition Overview: This is a roles for highly motivated Registered Nurse to progress in their nursing career in a management role. In this role, you will be responsible for overseeing the nursing staff, managing resident care, and ensuring that all nursing protocols and procedures are followed. Key Responsibilities: Overseeing the nursing and healthcare...
-
Mechanical Design Project Engineeer
3 months ago
Wexford Town, Co. Wexford, Ireland Gemma Hayes Recruitment Full timeDue to continued growth and expansion, our client, an award winning Engineering company seek to recruit an experienced full-time, permanent Design / Mechanical / Project Engineer to join their team of over 40 engineers. Key Responsibilities: Work within a team of over 40 Engineers. Develop and produce designs, models, and drawings in Solid Works for bespoke...
-
Senior Mechanical Estimator, Wexford
7 days ago
Wexford Town, Co. Wexford, Ireland Design Build Search Full timeDesign Build Search are working with a leading building services Engineering contractor who have an opportunity for a Senior Mechanical Estimator. The applicant will be based in our clients Wexford office. Within this position you will report directly to Senior Management. Scope of projects include: Commercial Food and Beverage Life science Residential...
-
Global Regulatory Affairs Specialist II
2 months ago
Wexford, Ireland Waters Corporation Full timeOverview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to new product development teams to ensure product requirements/design inputs and design outputs enable identified planned regulatory filings. Prepare, execute and maintain regulatory filings including change...
-
Senior Development Scientist
4 months ago
Wexford, Ireland Waters Corporation Full timeResponsibilities Lead product development team, supervise laboratory work for product development staff. Train and mentor new technical staff. Plan and perform design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products. Develop, test and refine prototype products. Generate test protocols, review and...
-
School Safety Officer
3 months ago
Wexford, Ireland Michigan School Public Relations Association Full timePosition Details DESCRIPTION OF BASIC FUNCTIONS, REPONSIBILITIES AND QUALIFICATIONS Bachelor or Associate degree in a law enforcement related field is preferred. Under the direction of the superintendent, and in cooperation with the elementary and JR/SR high school principals, the school safety officer coordinates and oversees all aspects of security...
-
Senior Development Scientist
4 months ago
Wexford, Ireland Waters Corporation Full timeOverview An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team is responsible for a diverse range of activities including analytical development, product development, verification and validation and on-market support. Responsibilities Lead product development team, supervise laboratory...
-
Development Scientist
4 months ago
Wexford, Ireland Waters Corporation Full timeResponsibilities The successful candidate will: Perform and plan design verification and analytical validation studies in the laboratory for In Vitro Diagnostics products. Develop, test and refine prototype products. Generate test protocols, review and analyze results, and generate V&V reports per current applicable technical guidelines and the...
-
Development Scientist
4 months ago
Wexford, Ireland Waters Corporation Full timeOverview An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The team is responsible for a diverse range of activities including analytical development, product development, verification and validation and on-market support. Responsibilities The successful candidate will: Perform and plan design...
-
Site Engineer
13 hours ago
Wexford, Ireland ICDS Full timeSite Engineer | All levelsWexford Town | Residential & CivilA well-established Residential Developer is seeking Site Engineers of all levels for new projects in Wexford Town. Candidates must have at least 2 years setting out experience.Site Engineer Responsibilities: * Setting out * Site Supervision & Coordination * Quality Control & Assurance * Health &...
-
Packaging Engineer II
2 weeks ago
Wexford Town, Co. Wexford, Ireland BD Medical Full timeJob Description Summary As the Packaging Engineer, you will be responsible for leading the successful development and implementation of new packaging designs, executing tests and ensuring appropriate industry and corporate standards are met. Working with and developing strong relationships with all internal and external business partners to develop package...