Job Title: Quality Engineer
Department: Quality
Status: Full Time
Location: Cork, Ireland Facility
Reporting To: Quality Manager, dotted line to Site Lead
Position Purpose:
The Quality Engineer performs quality activities concerned with continual improvement of products, processes, and materials, by applying quality and reliability disciplines. This position follows business processes, procedures and work instructions affecting quality of the design and manufacture of products and processes. This position is responsible for assisting in development and implementation of measures, reports, and monitoring results to determine areas for improvement.
Responsibilities
Ensures compliance to external and internal Quality Standards for Manufacturing and Product Development
Follows policies and procedures for identifying, analyzing risk throughout the product life cycle
Support product and process risk control measures (i.e., pFMEA, dFMEA risk evaluation) and risk management files (i.e., control plans, reports, safety profiles)
Assists in evaluations, tests, and decisions to maintain Quality Objectives
Follows Quality Processes, Procedures and Techniques
Assists on actions related to Internal Non-Conformities, Manufacturing Deviations and Corrective and Preventative Actions
Assists in audits and investigations of products, services, or internal business processes to identify and correct issues causing non-compliance of product to specification, escape of non-conformances to customers or ineffectiveness of a business system to achieve its intended purpose
Assists in equipment calibration and maintenance program as necessary
Perform Device History Record (DHR) review to ensure manufacturing documentation are accurate and complete as necessary
International site specific responsibilities
Participate in transfer, validation, and calibration processes.
Controlling, updating, and retaining all quality documents, and ensuring that changes and revisions are identifiable and communicated accordingly.
Comply with and strictly adhere to all requirements, tasks, and obligations derived from Harland Medical System’s Quality Management System.
Comply with the Occupational Health recommendations, standards, programs, and use of personal protective equipment (PPE) established by Harland Medical Systems and report through the appropriate channels about improvements to prevent incidents or occupational diseases.
Support and/or perform other duties as required
Education, Qualifications & Experience
Knowledge of compliance to ISO 13485: 2016 and QSR (FDA)
Minimally, understand and apply knowledge of ISO 17025: 2017
Ability to follow business systems, policies, procedures, work instructions, and specifications.
Strong Analytical / problem solving skills with a demonstrated ability to collect, summarize and report technical information.
Strong computer competency in MS Office - Word, Excel, and Outlook.
Detail oriented, highly organized individual
Integrity, high ethical standards
Excellent verbal, interpersonal and written communication skills
Self-starter, and motivated individual who works independently
Bachelor’s degree in engineering or science
ASQ CQE preferred
3 – 5 years’ experience working in the medical device industry
ISO 13485:2016 certified preferred
Authority
Report to management on the performance of the Quality Management System, and any need for improvement.
Ability to stop production line due to a non-conformance.
Make quality-related decisions on the production line.
Implement process improvements such as lean, etc.
For Laboratory sites:
Ensure the effectiveness of laboratory activities.
Committed to impartiality and confidentiality, including not allowing commercial, financial, and other pressures to compromise impartiality.
Working Conditions and Health & Safety
Heated and air-conditioned office environment
ISO Class 7 Cleanroom
Laboratory
Some International travel required (10-15%)
Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space
Harland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.
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