JOB DESCRIPTION

Job Description: Principal Design Assurance Engineer

Position: Principal Design Assurance Engineer
The role of Principal Design Assurance Engineer is to be 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 13485, CFR820 (QMSR) and governing Regulatory Standards associated with the product classification.

Lead the following activities from a quality perspective:
* 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

Key Responsibilities
* 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 13485:2016, EU MDR and international regulations.
* Excellent communication, leadership and problem-solving skills.

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