Search Results: 14 vacancies
...History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements.
Provide design assurance oversight and active participant in all stages of design development, testing and design control activities, ensuring quality assurance...
...- Manage project sub-parts, as part of a larger project team.
- Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
- Support regulatory submissions and lead additional Design Verification/Validation studies...
...salaries, benefits & career progression opportunities
What you will be doing:
* You will be responsible for providing validation oversight and take full ownership of the validation requalification and/or projects supporting the manufacturing operations.
* Lead a team of...
...risk management ; Design verification & validation to identified hardware-related standards.
Liaise with, and provide technical oversight of, third-party development partners in the design, building, and testing of the electronic systems.
Develop expertise in the realms...
...clinical programs include first in human, pilot, pivotal and post-launch studies. You will manage multiple operational studies, provide oversight throughout the development, implementation and conduct of clinical studies globally, develop study plans and project deliverables....
...advance of meetings.
Maintain accurate and effective records management to comply with legislative and organisational requirements.
Oversight of the delivery of the Internal Audit Plan.
Procurement and contract management as required.
Assist the Board Secretary, as...
...within IDEM and ensure compliance and connectivity to the broader design assurance process requirements.
Provide design assurance oversight to all functions operating in the New Product Introduction area.
Define clear roles and responsibilities for all functions to...
...processes are in place for all design lifecycle activities.
Requirements:
Provides technical leadership and centralized technical oversight for the R&D organization in the planning, development and execution of technical projects to achieve critical strategic business...
...of pump head functional requirements into control system output requirements and a detailed design specification.
- Ownership and oversight of the electro-mechanical design of control system (console, actuator & pump elements).
- Continuous calibration of the driver requirements...
...and continuous improvement. The position reports to the Quality Manager.
Role Responsibilities and Duties:
Provide compliance oversight and guidance for design transfer activities, as assigned.
Maintain awareness of applicable quality standards that regulate our industry...
...Responsibilities:
Provide support to the implementation of the applicable quality system at ARDx ID Galway.
Provide compliance oversight and guidance for design transfer activities for both entity & IVDR transfers and NPI, as assigned.
Maintain awareness of...
...talent.
Manage product investigation workloads and processes to ensure timely investigation and escalations as required
Provide oversight to work done offsite and by 3rd party vendors.
Determine appropriate staff levels, schedules, and resources.
Work cross-...
...This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight particularly in the areas of polymer/metal forming and micro assembly processes.
The Technical Life Cycle Management and Engineering...
...This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight.
The Technical Life Cycle Management and Engineering (TLCME) team are tasked with collaborating with R&D to provide technical expertise...