Boston Scientific Quality Director 

Ireland, Cork 

128823313

• Location: Cork
• Contract Type: Permanent
• Reporting to: Vice President, Quality
• Closing Date: 24th July

The Director of Operations Quality leads a team of Managers, Principals, Associate Managers, Senior Engineers, Engineers, Technicians, and other professionals to ensure full compliance to all GMP/QSR practices and standards as defined by the EU MDR, Food and Drug Administration, ISO and other regulatory bodies.

Responsibilities

• Demonstration of commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and ensuring the BSC Quality Management System and where applicable the Cork Pharmaceutical Quality System (PQS) is fully implemented to comply with requirements.
• Responsibility and independent authority to make decisions related to product quality including the disposition of non-conforming product.
• Providing leadership and direction to their team and ensuring a Quality Management System and where applicable PQS exists to meet regulatory requirements. Specifically, they will ensure the necessary monitoring of and management of processes including storage, retention and review, establishment of internal auditing programs, verification of all products and processes to the established quality standards and validation of new products/processes or changes to existing products/processes.
• Building strong and sustaining relationships with internal colleagues and functions including Production, Engineering, Global Quality, Regulatory, divisional stakeholders, and others as needed.
• Interfacing and building effective communication and relationships with external Regulatory bodies.
• Demonstration of commitment to developing people and recognition as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in his/her/their everyday leadership style.
• Demonstration of effective change leadership capabilities, and recognition as a team player across the organization.
• Ensuring that the necessary monitoring systems are implemented, and signals responded to for production & process controls, document and records controls, design controls, material and supplier controls, post market feedback, product approvals and CAPA.
• Directing and controlling the Quality budget in collaboration with relevant stakeholders.
• Communication of quality policies, strategies and procedures to the organisation through written documents, presentations and discussions.
• Monitoring and ensuring compliance with company policies and procedures.
• Continuously fostering and driving a continuous improvement approach to Quality and ensuring that quality is the responsibility of everyone.
• Ensuring that the Quality System is an integrated and integral aspect of the total running of the Site.
• Ensuring that the Corporate Quality objectives are appropriately cascaded to the Cork site, in the form of site Quality objectives.
• Has responsibility for representing the site(s) to external Quality System Assessment agencies, such as Notified Body Representatives, Federal Food and Drug Agency Inspectors, ISO accreditation and Global Quality Compliance Auditors.
• Ensures that the quality organization is effectively resourced and trained to perform their duties and their training is documented.

Qualifications & Experience

• Level 8 in Science or Engineering (Level 9 desirable)

• Experience in managing large-scale, complex operations/programs/projects.
• In depth knowledge of Quality Systems, Medical Device manufacturing and regulatory requirements over a minimum of 9 years.
• Experience with BSC Quality systems and methods, products, and customer needs.
• Pharmaceutical Manufacturing experience desirable.
• Lean business/VIP experience.
• Experience leading teams in a site quality setting.
• Established experience in leading and solving complex problems and strategies.
• Financial experience in cost centre planning and execution responsibility.
• Excel in Collaborative Leadership with the ability to influence.