Our client, a world leader in scientific technology and engineering are in search for a Manufacturing Quality Engineer to permanently join their Irish-based operations in Dublin. The role will involve joining responsibility for all quality related activities associated with their new product and process development, ensuring the planning and management of all quality relative activities, to ensure that the goods product meet their desired specification.
Managing the quality of purchased goods by:
o Assisting with vendor selection and executing the inspection process
o Planning and supervising incoming inspections
o Pursuing quality issues with suppliers to ensure their prompt resolution
Responsible for managing the quality of assembly operations by:
o Reviewing and approving various process control measures deployed in the assembly cell to ensure conformity of product
o Monitoring and analysing production quality indicators to identify possible issues and to provide drive for corrective and preventive action
o Ensuring that nonconforming material is suitably segregated, investigated and disposed of and ensuring that an appropriate corrective action is taken.
Responsible for maintenance of the continued operational status of the facilities by:
o Ensuring processes and measurements methods are suitably validated in conformity with validation practices for medical devices
o Managing maintenance and calibration of equipment to ensure its continued state of operation
o Monitoring the status of compliance of the assembly areas with their environmental control requirements
Responsible monitoring the status of compliance by:
o Ensuring that records are produced in conformity with planned arrangements and in compliance with GDP rules
o Ensuring training requirements are suitably identified and implemented
o Checking periodically through auditing techniques that manufacturing operations are performed in compliance with procedures.
Responsible for providing overall quality support to the team by:
o Working in close relationship with the design team to develop a full understanding of the product.
o Participation in the various risk assessments carried out to ensure conformity of the product manufactured.
o Ensuring that any change required analysed, validated and implemented in accordance with change control rules.
• A degree in a quality management, mechanical or production engineering or related discipline
• A minimum 3-5 years industry experience within the quality side of the medical device or similarly regulated industry.
• Manufacturing tooling experience and prototype development.
• Good working knowledge in the fields of process validation, equipment qualification (IQ/OQ/PQ), statistical process control and design for manufacturing
• organisation skills, with the proven ability to test products and materials both methodically and accurately.
• Demonstrate the ability to work within a cross-functional team and to adapt contribution to meet the team's expectations.
• Strong communication skills
• Demonstrate problem-solving possess and troubleshooting skills
• Experience/knowledge in NDP, metallurgy and materials analysis, injection moulding and plastic materials properties, is considered an advantage
• Experience in performing audits and compliance with quality management standards is considered an advantage. pursue issues until their resolution.
If you would like further Information you can contact the recruiter directly:
Oran McIvor | Tel: +353 (0) 1 507 9270