Job Opportunity
A rapidly growing medical device manufacturer is seeking a seasoned Operations Manager to lead and optimize its expanding operations, facilities, and supply chain functions.
Key Responsibilities:
* Manufacturing Operations: Plan, manage, and execute day-to-day manufacturing activities, both in-house and with contract manufacturing partners (CMOs).
* Lead the setup of assembly lines within class 8 cleanroom environments.
* Develop and refine scalable processes, systems, and operational philosophies.
In collaboration with cross-functional teams, foster strong supplier relationships to meet targets across quality, cost, and delivery. Drive manufacturing readiness for clinical and commercial supply.
Facilities Management:
* Oversight of maintenance, safety, and compliance of facilities in collaboration with internal teams.
* Manage facility upgrades to meet evolving operational requirements.
* Liaison for external contractors and service providers.
Supply Chain & Procurement:
* Lead the full supply chain strategy, including procurement, logistics, inventory, and supplier management.
* Develop a supply planning process to ensure uninterrupted availability of components and finished goods.
* Monitor and optimize supplier performance; identify and qualify alternative sources as needed.
Leadership & Compliance:
* Recruit, train, and mentor operations staff as the team expands.
* Manage cross-functional teams in production, manufacturing, and supply chain.
* Implement and monitor KPIs, dashboards, and performance metrics.
Ensure full compliance with relevant regulatory frameworks, including ISO 13485, GMP, and FDA 21 CFR Part 820. Champion continuous improvement initiatives across operational areas. Contribute to strategic planning, budgeting, and execution of long-term operational goals.