MDR – Quality Engineer
Job ID: JOB-11714
Title: Quality Engineer – MDR
Duration: 12 months
Location: Parkmore once restrictions lift / WFH at Start
Our client is a well-known Galway based multinational with sites across Ireland with an opportunity for an experienced Quality Engineer – Process Validation to join a high performing team! As the Quality Engineer – Process Validation, you will support the validation requirements for a product transfer to the Galway site providing input to process development and process validation.
KEY RESPONSIBILITIES: (Not limited to the below)
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
- We are looking for a person qualified to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 2 years relevant experience.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams.
- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
- Knowledge of regulatory requirements and guidelines including 21 CFR part 820, MDR and ISO 13485 requirements is necessary.
- You are a good communicator and fluent in English, both in writing and speaking.
SPECIALIST CAREER STREAM:
- Typically an individual contributor with responsibility in a professional discipline or specialty.
- Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower level professionals.
- The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
- Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
- Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
- Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
- Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
For further information on this role please contact Shane Connolly on 0872197421 or firstname.lastname@example.org
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