Quality Engineer II
About Your New Employer
- Join a leading company in the medical device industry.
- Be part of a dynamic team in a state-of-the-art facility in Cork, Ireland.
- Work in an environment that values innovation, quality, and continuous improvement.
About Your New Job
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g., Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
- Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost, and output.
- Ensure all process variables and their interactions are adequately defined and all failure modes in the process have been identified and addressed (e.g., Use of DOE studies, FMEA’s).
- Drive and implement plant-wide quality system improvements.
- Ensure Regulatory compliance in the area of responsibility to cGMP’s of all medical device regulatory agencies (e.g., FDA and TUV).
- Provide functional expertise to other support functions on quality-related issues (e.g., regulatory requirements, statistical techniques, sampling principles).
- Identify and implement appropriate statistical techniques to monitor process performance (e.g., SPC, CpK analysis, sampling techniques).
- Approve change requests for product, process, and quality system changes.
- Analyze customer complaints, approve analysis reports, and analyze complaint trends.
- Define process, product, and test method validation requirements, prepare and approve Master Validation Plans, protocols, and reports.
- Compile required Regulatory documentation (e.g., Technical files, Design Dossiers, Product transfer files, Essential requirements).
- Review MRB trends and identify appropriate corrective actions when required.
- Support the implementation of Lean Manufacturing across the site.
What Skills You Need
- Minimum of a Bachelor of Science Degree in Engineering/Technology.
- 3/4 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
What’s on Offer
- Competitive salary and benefits package.
- Opportunities for career growth and development.
- Work in a collaborative and innovative environment.
What’s Next
Apply now by clicking the “Apply Now" button or contact Karolina at kjaglowska@sigmar.ie . If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
