Executive / senior industry position
Act as a member of the Boston Scientific Cork facility quality team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
- Supervision of Quality Technicians and Quality Engineers.
- 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: Approval of analysis reports and analysis of complaint trends.
- Validation: Define process and product 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.
- Transfer and implement product and processes from development or from another manufacturing facility.
- Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities.
- Excellent interpersonal and communication skills with good leadership abilities.
- Ability to work as part of a team and meet targets/goals efficiently.
- Excellent analytical and problem-solving skills.
- Minimum of 4+ years’ experience within the medical device or pharmaceutical manufacturing industry - people management experience an advantage.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.