POSITION DESCRIPTION
Senior Quality Engineer 12 month Contract
ABOUT ITW MEDICAL:
Founded in 1912, Illinois Tool Works Inc. (NYSE: ITW) is a diversified, Fortune 200 manufacturing company that delivers specialized expertise, innovative thinking, and value-added products to meet critical customer needs in a variety of industries. Ranked among Fortune’s Magazine’s most admired companies, the company focuses on solid growth, improving profitability and strong returns across its worldwide platforms and divisions. These divisions serve customers and markets around the globe, with a significant presence in developed as well as emerging markets. ITW’s revenues totaled $14.6 billion in 2023
ITW Medical is comprised of two highly-respected medical product brands - Coeur & Filtertek – supplying medical devices and components to global medical device brands. Filtertek manufactures molded filtration and flow control components. Coeur is a leading provider of disposable diagnostic imaging consumables.
General Accountability:
This position will report to ITW Medical’s Global Quality Director. The individual will be responsible for validations, scrap reduction and continuous improvement activities. The individual will ensure that projects are implemented, internal/external quality issues are investigated, and root cause and corrective/preventive actions are identified and executed. This position is for the Newcastle West site in Limerick Ireland
Duties and Responsibilities:
· Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA) creation
· Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results
· Manage Implementation and Documentation of IQ, OQ, PQ.
· Ensure timely and conclusive validations.
· Update existing inspection plans, control plans, test methods, and standard operating procedures
· Conduct sample size determination, statistical analysis, training, and root cause analysis
· Take lead in understanding/updating FMEA for new failure modes
· Assist the Quality Department at NCW to maintain a compliant and audit ready Quality Management System (ISO13485, FDA QMSR)
· Drive and actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives
· Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects.
· Manage small Quality Team to ensure resources are maximized to support both the sites and its Customers
· Lead cross-functional teams in continuous quality improvement projects in scrap reduction and identification and elimination of non-value-added activities
· Take lead in collection, review, analysis, and trending of quality indicators for monthly and quarterly reviews
· Manage and contribute to problem solving teams using standardized investigation processes/tools.
· Participate in the Internal Audit process and assist in addressing observations
· Participate in customer and regulatory body audits
· Ensure a compliant and audit ready Quality Management System ( ISO13485 , FDA QMSR )
- Other tasks and duties assigned
Job Requirements:
· Bachelor’s degree (required) in an Engineering or related field.
· 5-6 years related experience (required) in Medical Devices Industry (preferred).
· Ability to perform routine design and engineering tasks with some assistance.
· Solid understanding of engineering and mathematics principles.
· Ability to interpret product requirements from drawings, specifications, blueprints, etc. and to identify and drive corrections of inconsistencies or inaccuracies in same
· Knowledge of PPAP, FMEA, Lean Sig Sigma , Continuous Improvement and Root Cause Analysis Tools is desired.
· Highly motivated, detail-oriented, eager to drive needed change in the organization
· Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
· Experience of working with Customers in defining KPI’s , reporting on issues, responding to Complaints, driving continuous improvement projects would be preferred.
· Excellent time management, prioritization abilities, and strong project management skills
· Ability to develop, implement, and present strategies to gain support
· Strong analytical skills, with 80/20 mindset
· Ability to work with and manage complexity/change such that implementation is simplified
· Demonstrated ability to analyze data and make sound, enterprise-first, decisions
· Excellent interpersonal, communication, and presentation skills
· Personally driven and able to motivate others to excel
· Ability to use MS Office Tools such as Word, Excel, Project, Access and MiniTab®.
Pay: €60,000.00-€70,000.00 per year
Benefits:
- Bike to work scheme
- Company events
- Company pension
- On-site parking
- Private medical insurance
- Sick pay
Ability to commute/relocate:
- Newcastle West, County Limerick: reliably commute or plan to relocate before starting work (required)
Application question(s):
- How many years Medical Device experience do you have?(Advantage)
Education:
Experience:
- Quality : 5 years (required)
Work authorisation:
Work Location: In person
