Principal Design Assurance Engineer- Medical Device
Permanent
Galway
Job Description
Overview: Principal Design Assurance Engineer is the QA technical and compliance expert as part of a cross functional team for the design and development of sterile and non-sterile medical devices and/or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO *****, CFR820 (QMSR) and governing Regulatory Standards associated with the product classification.
Responsibilities
Risk Assessments
Device testing and associated validations
Audits (internal and external), Support as SME for design processes
Generation and/or approval of technical documents on behalf of the Quality Function
Manage DHF
On-going continuous improvement of the QMS
Responsible for compliance of product development and risk management activities with Medical Policies and Procedures and applicable Governing Regulatory Requirements
Work effectively as part of product development team in identifying and translating user requirements and inputs into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc.
Complete design verification, design validation and test method validation activities associated with product development activities
Works with R&D and Manufacturing Engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of appropriate production process monitoring activities
Leads the resolution of project issues by working with team members, suppliers, and others as appropriate
Generate and/or Review and approve all operational, test and validation data associated with equipment, materials, components, sub-assemblies and final product
Provides technical quality guidance to team members, technicians and inspection staff
System Administrator for Minitab
Ensure compliance to the QMS per QM001 quality manual
Essential Skills/Experience
Minimum Bachelor\'s Degree in Engineering, Science or related technical field
6 years QA, Quality System or regulatory experience in the medical industry
Strong knowledge of FDA 21 CFR Part 820, ISO *****:****, EU MDR and international regulations
Excellent communication, leadership and problem-solving skills
At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services.
See our website for more details.
Privacy Policy:
By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions.
For more info see wallacemyers.ie/privacy-policy
#J-*****-Ljbffr