Act as a member of the Boston Scientific Cork quality team.  To provide expert QA support to the establishment of the Pharmaceutical Quality system and then ongoing support to Operations, in ensuring operational goals and objectives are achieved for the plant. The Quality Engineer will play a key part in establishing and leading performance improvement of both inbound and outbound process by engaging and working with a cross functional team to ensure adequate procedures and processes in place to consistently meet Boston Scientific’s requirements.

Responsibilities

• Own, author, review and/or approve reports, procudures and validation documents in support of establishing pharmaceutical quality system to GMP requirements. 
• Be the Subject Matter Experts regarding Acceptable Quality Standards and GMP practices for products and processes.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects.
• Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
• Evaluate quality events ensuring compliance with cGMP and quality standard requirements. Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. Ensure timely and effective actions are implemented and that CAPA effectiveness checks are conducted.
• Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed.
• Ensure Regulatory compliance in area of responsibility for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.)
• 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.
• Approval of change requests for product, process and quality system changes.
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
• MRB: Review of MRB trends and identification of appropriate corrective actions when required.
• Support the implementation of Lean Manufacturing across the site.
• Transfer and implement product and processes from development or from another manufacturing facility.

Requirements:

• 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
• Excellent written and verbal communication skills
• Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
• Strong command of MS Office – Word, Excel, PowerPoint.
• Ability to rapidly learn and use new applications

Preferred Qualifications: 

• Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems
• Experience in the pharmaceutical industry and GMP manufacturing
• Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls.
• Experience in problem solving and process improvement methodologies
• Process Validation, Risk Management, CAPA experience.