Job Description Summary
You will support manufacturing of peripheral interventional devices. This role will represent quality interests and concerns on day-to-day quality operations to ensure conforming materials are available for manufacturing and customers. You will work on problem-solving and investigations to determine the root cause of material non-conformances so that issues are resolved to close out with no recurrences. The role will work closely with the different functions.
About the role
As a Quality Engineer, you will support manufacturing peripheral interventional devices. This role will represent quality interests and concerns on day-to-day quality operations to ensure conforming materials are available for manufacturing and customers. You will work on problem-solving and investigations to determine the root cause of material non-conformances so that issues are resolved and closed with no recurrences. The role will work closely with the different functions.
Main responsibilities will include:
1. Ensures compliance with quality system requirements as defined by BD Technologies, procedures, FDA QSR, ISO 13485, and applicable international and national standards (e.g., EN, ASTM).
2. Provides Quality representation to support the day-to-day operation of the business.
3. Experience in risk management tools, specifically PFMEA, and how process changes can impact existing risk assessments.
4. Experience in validation, including assessing the impact of changes to existing processes and the review and approval of process validation documentation (IQ, OQ and PQ).
5. Ensuring continued material compliance and timely disposition of non-conforming materials from Incoming Quality Control or Manufacturing Processes.
6. Demonstrated experience in the use of root cause analysis tools and problem-solving techniques.
7. Supports continuous improvement initiatives related to quality processes to drive performance and compliance.
8. Demonstrated experience in change control systems, including creating/updating various documents or procedures and reviewing quality documentation to ensure accuracy and compliance with procedures and regulations.
9. Demonstrated ability to use data analysis to drive solutions that can improve the quality of a process, such as NCMR reduction, defect reduction, inspection improvements, etc.
10. Supports metrics and regulatory reporting following the relevant Corporate, Local and International Requirements.
About you
1. Minimum third-level qualification (Degree level), preferably science or engineering.
2. 3 Years of Experience in a Regulated Industry, including QA, compliance, and/or Regulatory Affairs.
3. Strong working knowledge of QSR, ISO 13485 MDR and FDA requirements.
4. Experience conducting quality audits and inspections is desirable.
Primary Work Location
IRL Wexford - Enniscorthy
Work Shift
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