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TekPro

Director of Operations

TekPro, Billerica

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About HydroCision

HydroCision is an innovative medical device company specializing in advanced fluid-based surgical instruments for spine and wound care procedures. With manufacturing and engineering support spanning both the U.S. and China, we deliver high-quality, precision devices that improve clinical outcomes and patient care.

Our Billerica, MA office serves as the strategic and operational hub for our U.S. operations. We are a small but highly capable team, and we’re seeking an experienced Operations Director to drive manage global supply chain coordination, oversee day-to-day operations and elevate our quality systems.

Position Overview

This is a critical leadership role for a hands-on, results-driven Operations Manager who can oversee and optimize the company’s end-to-end supply chain, quality assurance, vendor management, and planning. You will work closely with the cross-functional team in Billerica (3 direct reports) and regularly collaborate with our contract manufacturing and sourcing teams in China (approx. 20 employees).

This role requires a strong background in supply chain operations, medical device quality systems , and international manufacturing coordination .

Key Responsibilities

  • Manage day-to-day operations including supply chain logistics, inventory management, and procurement

  • Oversee production planning and ensure timely delivery of finished goods

  • Serve as the primary liaison between the U.S. office and our China-based manufacturing partners

  • Lead vendor evaluation, selection, and relationship management

  • Maintain and improve quality management systems (QMS) in compliance with FDA and ISO 13485 standards

  • Support regulatory and quality audits and ensure documentation is accurate and audit-ready

  • Drive process improvements to increase efficiency, reduce lead times, and ensure product quality

  • Provide operational input into forecasting, budgeting, and strategic planning

Requirements

  • 5–15+ years of experience in operations, supply chain, or manufacturing management

  • Prior experience in the medical device industry required

  • Strong knowledge of FDA regulations and ISO 13485 quality systems

  • Proven experience working with overseas manufacturing teams, especially in Asia

  • Ability to lead projects and teams across time zones and cultures

  • Excellent problem-solving, communication, and organizational skills

  • Bachelor’s degree in Operations, Engineering, Supply Chain, or a related field

What We Offer

  • Competitive base salary with performance bonus and equity piece

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