Engineering & Electronics
PE Global is currently recruiting for a Quality Engineer on behalf of our client based in Galway. This is an initial 12 month contract role.
- Provides QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs.
- Assures compliance to applicable regulations and completes quality activities such as risk assessments, device testing, QMS/data audits, procedure development, documentation review and changes to controlled documents.
- Provides design control, risk management and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.
- Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the Design Control and Risk Management processes.
- Provides Quality support/guidance to R&D and Lifecycle Management projects leads/team members.
- Resolves project issues by working with team members, suppliers, and others as appropriate.
- Applies thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Manages and maintains the records related to design control applicable to product development and design/manufacturing change projects.
- Contributes and participates in design review meetings.
- Provides input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
- Provides input into development of protocols / reports supporting the Design control process.
- Provides input and review to protocols and reports for sterilization, biocompatibility and packaging validations.
- Co-ordinates the timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the product.
- Co-ordinates the review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design reports.
- Supports bench test activity as required.
- Supports the translation of the design requirements into manufacturing requirements.
- Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.
- Administration and management of systems for CAPA, non-conformances and for supplier corrective actions.
- Leads and/or facilitates compliance and improvement activities associated with the Quality System (e.g. CAPA).
- Prepares data as applicable for use in management review.
- Supports internal/Supplier audits as applicable.
- Supports regulatory activities as requested by management.
- Represents professionally and positively externally to agencies, vendors and regulators.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Education and Experience:
- Minimum education of degree in a technical field is preferred.
- Minimum 2 years’ experience in the medical device industry and/or IVD/pharmaceutical preferably in a design quality role.
- Knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes beneficial.
- Knowledge of QMS requirements and processes.
- Knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.
- Ability to discern major quality issues.
- Ability to work well under deadlines and pressure.
- Ability to work on own initiative and as a team player.
- Ability to build good, strong and positive working relationships with cross functional teams internationally.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***