PR/095842 | Head of Operations

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