Job Title: Manufacturing Quality Engineer – MedTech
Location: Cork, Ireland
Job Type: Full-time
About the Role:
We are seeking a highly skilled Manufacturing Quality Engineer to join our MedTech team. The successful candidate will be responsible for ensuring the highest standards of quality in medical device manufacturing by implementing and maintaining quality systems, driving process improvements, and ensuring compliance with regulatory requirements.
Key Responsibilities:
* Quality Assurance & Compliance: Ensure compliance with FDA (21 CFR Part 820), ISO 13485, MDR, and other applicable regulations.
* Process Validation & Improvement: Lead IQ/OQ/PQ validations, root cause analysis, and corrective & preventive actions (CAPA).
* Supplier & Vendor Management: Work with suppliers to maintain quality standards, conduct supplier audits, and drive quality improvements.
* Manufacturing Support: Collaborate with production teams to resolve quality issues and implement continuous improvement initiatives.
* Risk Management: Apply FMEA (Failure Modes and Effects Analysis) to identify and mitigate risks in manufacturing processes.
* Nonconformance Handling: Investigate nonconformances, deviations, and defects, and develop corrective actions.
* Document Control & Reporting: Maintain accurate records, generate reports, and contribute to internal and external audits.
* Cross-functional Collaboration: Work closely with R&D, regulatory affairs, and operations teams to ensure smooth product lifecycle management.
Qualifications & Skills:
* Bachelor’s degree in Engineering, Quality, or a related field.
* 3-5+ years of experience in quality engineering within medical device manufacturing.
* In-depth knowledge of ISO 13485, FDA regulations, and GMP.
* Experience with root cause analysis, Six Sigma, and Lean Manufacturing principles.
* Proficiency in quality tools such as SPC, Minitab, or other statistical analysis software.
* Strong analytical and problem-solving skills.
* Excellent communication and teamwork abilities.
* ASQ Certification (CQE, CQA, or Six Sigma Green/Black Belt) is a plus.
#J-18808-Ljbffr