- Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
- Conduct detailed root cause analysis and define corrective and preventive actions for NCR.
- Management of the calibration of QA, Product and Engineering equipment
- Work with engineering teams to identify trends in failures, support root cause analysis and implementation of corrective actions
- Conduct Internal audits.
- Develop Inspection plans for Incoming inspections, in process and Final QA inspection for products manufactured
- Detailed Review and approval of Risk Managements files
- Review and Approval of Change Orders associated with components and manufacturing process,
- Provide Operational QA Support for products and process.
- Lead / team member of CAPA as required
- Oversight and management of the MRB process
- Lead KATA investigations towards root cause
Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical) .
- Three to five years of experience in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
- Accredited Lead/Biomedical Auditor certification strongly preferred.
- Knowledge of IEC 60601 electrical safety standards and RoHS and WEEE regulations strongly preferred.
- Lean/Six Sigma certification strongly preferred.
- Strong project management skills required.
- Demonstrated knowledge of statistical sampling and analysis.
- Demonstrated excellent organizational, writing and verbal communication skills
- Proficient with the MS Office Suite, including Microsoft Visio and Project.
- Experience working in Oracle, Agile and TrackWise systems preferred
- Demonstrated knowledge of FDA regulations, applicable medical device/quality system ISO standards, CMDR, MDD and other national and international regulations and standards.
- Must be able to work independently with minimal supervision.
For more information or a confidential discussion on the role, please contact David Lennon