Sr Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

Responsibilities may include the following and other duties may be assigned.
• Undertakes and successfully completes complex test method development tasks including: creation, writing, test method validation, equipment qualification and supporting on-going maintenance of test methods.

• Leads or participates in a cross functional team to translate product specifications into test methods.

• You will liaise with extended team members to facilitate timely completion of Test Method Validation
activities.

• Devise strategies for efficient execution of project deliverables and co-ordinate activities of a number of staff in an assigned phase of a development project.

• You will provide technical expertise in test method development and validation supporting new development projects.

• You will liaise with other functions to ensure robust test method development meeting all stakeholders’ requirements.

• You will generate new test methods and test method related equipment and fixtures with all supporting materials.

• Lead and solve complex problems to resolution and solution implementation.

• As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialization activities.

• Translates international standards and regulatory guidance into test methods.

• Works independently to plan and schedule own activities necessary to meet timelines.

• 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.


Education & Experience

• We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and desirably with a minimum of 5 years relevant experience.

• Experience with Solidworks or CAD Software, fixturing or model fabrication, anatomical knowledge, statistical knowledge.

• 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.

• You are a good communicator and fluent in English, both in writing and speaking.