About Your New Employer
Boston Scientific are a global medical device company that helps save a life every 5 – 8 seconds across the world. Not only that, but they also offer excellent benefits and amazing, structured career development plans.
This role involves being responsible for line support quality activities for the Polymer Core Technology unit.
About Your New Job
- Supervision of Quality Technicians.
- 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. Ensure all failure modes in 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 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).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
- MRB: Review of MRB trends and identification of appropriate corrective actions when required.
- Perform internal quality audits.
- Support the implementation of Lean Manufacturing across the site.
- Transfer and implement product and processes from development or from another manufacturing facility.
What Skills You Need
- Minimum of Bachelor of Science Degree in Engineering/Technology.
- 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a quality environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
What’s on Offer
- 10% Bonus
- 22 Days Annual Leave
- Up to 8% Pension Contribution
- Health Insurance
What’s Next
Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306
Or 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.
