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Key Responsibilities
Strategic Operations Leadership — Drive operational strategy aligned with overall business goals, encompassing capacity planning, footprint optimisation, and long-term growth initiatives.
Regulatory & Compliance Oversight — Ensure full compliance with ISO 13485, FDA regulations, GMP, and other applicable global requirements; maintain audit readiness at all times.
Quality Management & Continuous Improvement — Champion a strong quality culture; oversee CAPA and NCR processes; lead continuous improvement initiatives through Lean and Six Sigma methodologies.
Manufacturing & Production Excellence — Oversee daily manufacturing operations to ensure efficiency, yield, and on-time delivery while meeting stringent medical device requirements.
New Product Introduction (NPI) & Technology Transfer — Lead cross-functional NPI efforts, process validation (IQ/OQ/PQ), and seamless transfer from R&D to mass production.
Cost & P&L Ownership — Drive cost optimisation and productivity improvements; progressively assume site-level P&L ownership in preparation for General Manager responsibilities.
Engineering & Process Development — Oversee process engineering, automation, tooling, and innovation to improve manufacturability and scalability.
EHS Leadership — Ensure compliance with environmental, health, and safety regulations; foster a strong EHS culture to protect employees and operations.
Talent Development & Organisational Leadership — Build and develop high-performing teams; implement succession planning and develop the leadership pipeline, including mentoring future leaders.
Customer & Stakeholder Management — Act as a key interface with clients and sales; ensure customer satisfaction, manage escalations, and support business development efforts.
Digital Transformation & Systems Integration — Lead the adoption and optimisation of digital tools (e.g., MES, ERP, data analytics) to enhance operational visibility, traceability, and decision-making in a highly regulated environment.
Risk Management & Business Continuity — Identify operational risks across quality, supply, and regulatory domains; implement mitigation strategies and business continuity plans.
Commercial & Business Growth Support — Partner with Business Development teams on RFQs, cost modelling, and capability presentations; align operational readiness with growth opportunities.
Support ad hoc instructions from Directors and the CEO as required.
Requirements
Education — Bachelor’s degree or above in Electrical, Mechanical, Mechatronics, Industrial, or Manufacturing Engineering (or a closely related discipline)
Experience — Minimum 15 years of progressive experience in medical device manufacturing, with demonstrated expertise in quality systems, supply chain management, financial oversight, and continuous improvement leadership
Technical Knowledge — Deep understanding of medical device regulations, manufacturing processes, risk control frameworks, and operational leadership methodologies
Skills — Strong leadership, strategic thinking, data analysis, project management, stakeholder communication, negotiation, and a continuous improvement mindset
Personality — Resilient, decisive, accountable, and results-driven; calm under pressure with a collaborative, ethical approach and an unwavering commitment to excellence