Quality Engineer II
Our Client is seeking an experienced Quality Engineer II to join their progressive company. This client is a leading medical devices company based in South Tipperary have a collaborative culture driven by a passion for innovation that keeps them connected on the most essential level. With determination, imagination and a deep caring for human life, they are solving some of the most important healthcare industry challenges. Together, as one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Job Purpose: Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
- Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria
- Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects
- Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the quality system, such as development and manufacturing, as assigned
- Key partner in forming and evaluating the production area strategy for the production unit.
- Identify & lead quality projects to support Production Area Strategy.
- Quality lead on Production unit and quality process improvement projects.
- Lead on Preventive Quality initiatives in Production unit.
- Coordinates and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using Engineering Essentials.
- Leads investigations on customer internal & external complaints.
- Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes.
- Analyse preliminary plans and develop reliable engineering programs to achieve company, customer and governmental agency reliability objectives.
- Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
- Leads process improvement efforts by performing appropriate analysis methods to enhance sustaining product design and new product development.
- Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Be part of a strong team culture around high expectations & high performance.
- Provide clear communication to stakeholders at key technical updates
- Higher Level Degree qualification in Engineering/Quality/Science with a minimum 5 years’ experience in a Medical Device environment or related industry.
- Demonstrate strong leadership skills, communication skills and promote quality at source.
This is an excellent opportunity to join a world renowned company and grow your career