Work Flexibility: Onsite
This is a fully onsite role based at our Tullagreen site in Carrigtwohill, Co. Cork.
Lead the Quality Assurance team supporting JR Hip manufacturing, delivering the strategic, compliance, and business objectives of the function. This role is primarily responsible for developing and leading quality initiatives across Operations and other business functions.
Identify opportunities for efficiencies, risk-based approach, and competencies aligned with GQO and 1A customer strategies.
Collaborate closely with partner areas including Procurement, AO, Operations, and Quality Leadership to develop and implement an organizational vision, structure, and strategy to provide clear lines on communication accountability, and responsibility to support the growth of the business.
Working within the Manufacturing Quality Assurance structure, in a leadership capacity, has responsibility for quality related activities which includes, but not limited to the following:
Ensure that the organisation’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory standards.
Recognizes opportunities to maximize and increase efficiencies through continuous improvement, lean activities, and leverage across the business.
Lead and/or partner in deployment of manufacturing & automation systems to optimize manufacturing processes, supply chain, and business operations such as MES, CMMS, SPC, automation control and integration to key business systems such as ERP, PLM & PDM
Ensures the site(s) maintain continued certification to all regulatory bodies. Sponsors and ensures engagement in all internal and external audit programmes such as Corporate, notified body & FDA audits.
Ensures effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Holds site(s) accountable to managing product & patient risk.
Build a high performing QA team and wider community to maximise value from current QA processes. Shape an optimum operating model to standardise business processes, leveraged SMEs while driving consistent & sustainable QA processes.
Champions a positive employee environment by promoting open communication, engagement and development of team members. Promotes a culture of trust, flexibility, teamwork and inclusiveness, ensuring all relevant Quality functions (e.g., Shared Services Quality, Supplier Quality) are included in decision making processes as part of continuous improvement, problem solving and projects.
Engage in plant network strategy evaluation and deployment. Support development of a QA PT roadmap aligned with GQO strategy for sustaining growth by identifying future opportunities for leverage, capacity/capability, and future business benefits.
Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement.
With global alignment, develops a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management.
A track record of building high performing teams that deliver tangible results and achieving key performance indicators. Strong people leadership skills to inspire and guide teams through operational transformation.
Ability to adapt to changing business environments and technological landscapes, supported by strong influencing and negotiation skills. Is highly attentive to customer needs and oriented towards delivering exceptional service.
Qualifications, Knowledge & Skills
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
Demonstrate technical knowledge of medical…