Senior Production Manager

Senior Production Manager

CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drug abuse, biomarkers and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

We are seeking an experienced Senior Production Manager to oversee and optimize manufacturing operations in a regulated environment, ensuring compliance with ISO 13485 standards. The ideal candidate will have a strong background in production management within the medical device or healthcare manufacturing industry, driving efficiency, quality, and continuous improvement while maintaining compliance with regulatory and safety standards.

Responsibilities

Production Oversight: Manage daily manufacturing operations, ensuring production schedules are met while maintaining high-quality standards.

ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production.

Quality & Process Improvement: Work closely with Quality Assurance teams to implement and maintain Good Manufacturing Practices (GMP) and continuous improvement initiatives.

Regulatory Compliance: Ensure documentation, production procedures, and risk management align with FDA and ISO 13485 guidelines.

Team Leadership: Supervise and mentor production staff, fostering a culture of safety, accountability, and professional growth.

Lean Manufacturing: Utilize Lean, Six Sigma, and other process optimization techniques to enhance efficiency, reduce waste, and improve productivity.

Equipment & Maintenance: Oversee the maintenance and validation of production equipment to ensure compliance with quality and safety standards.

Supply Chain Coordination: Collaborate with procurement, logistics, and engineering teams to optimize material availability and minimize downtime.

Root Cause Analysis: Investigate production issues, implement corrective/preventive actions (CAPAs), and ensure compliance with ISO 13485 risk management principles.