Quality Engineer II
About Your New Employer
Our client is a renowned leader in the medical device industry, known for its innovative solutions and commitment to improving patient care. Join a team that works with the latest technologies and methodologies in the field. Our client offers numerous opportunities for professional development and career advancement.
About Your New Job
- Drive and Implement Process Improvements: Ensure predictable processes across all product lines, focusing on risk reduction, yield improvements, customer complaint reduction, error proofing, cost reduction initiatives, and process automation activities.
- Provide QA Support: Offer effective and responsive QA support to Operations to meet quality, cost, and output objectives.
- Ensure Process Variables: Define and ensure all process variables and their interactions are adequately addressed, including failure modes (e.g., DOE studies, FMEA’s).
- Quality System Improvements: Drive and implement plant-wide quality system improvements.
- Regulatory Compliance: Ensure compliance with GMP’s and medical device regulatory agencies (e.g., FDA, TUV).
- Statistical Techniques: Implement appropriate statistical techniques to monitor process performance (e.g., SPC, CpK analysis, sampling techniques).
- Change Requests and Customer Complaints: Approve change requests for product, process, and quality system changes. Analyse returns, approve analysis reports, and analyse complaint trends.
- Validation and Documentation: Define validation requirements, prepare and approve Master Validation Plans, protocols, and reports. Compile required regulatory documentation (e.g., Technical files, Design Dossiers).
- Lean Manufacturing: Support the implementation of Lean Manufacturing across the site.
- Product and Process Transfer: Transfer and implement products and processes from development or other manufacturing facilities.
What Skills You Need
- Educational Background: Minimum of a Bachelor of Science Degree in Engineering/Technology.
- Experience: 3/4 years’ experience in a manufacturing environment or equivalent, with direct experience in a QA environment (preferably GMP regulated).
- Industry Knowledge: Experience in the medical device industry is an advantage.
What’s on Offer
- Competitive Salary: €50,000 to €57,000 DOE plus Bonus
- Professional Development: Opportunities for training and career growth.
- Innovative Environment: Work in a dynamic and innovative environment with cutting-edge technology.
What’s Next
Apply now by clicking the “Apply Now" button or call me on +353 21 4847136 or email afitzpatrick@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.