Quality Engineer II
Duration:
12 Months
Location:
Galway
Job Type:
Onsite
Industry
: Medical Device
Non Negotiables
**You must be open to contract work, be currently based in Ireland and willing to be onsite in Galway full time
Responsibilities
Applies and maintains quality standards and protocols for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Apply knowledge of design control principles and quality engineering techniques throughout the product development process and the product lifecycle.
Applies and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of raw materials and test equipment
Collaborate with required stakeholders in the receive inspection function and across functions ensuring incoming materials and components meet defined specifications and regulatory requirements.
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.
Participate in preparing / critically reviewing/approving NCMRs/ Investigations, providing QA technical direction and solutions as appropriate.
Ensures effective product control measures in the event of issues being noted.
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.
Supporting internal and external audits (MDR/MDSAP/FDA etc).
Key Skills & Experience
Level 8 Degree in Engineering / Science or related discipline
minimum 2 years' relevant experience in a highly regulated industry.
You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams with a high level of enthusiasm and motivation.
Good communication, organizational, presentation and leadership skills are desirable.
Ability to work independently to plan and schedule own activities necessary to meet timelines highly desirable.
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
For further information contact Alan on