CorDx
Overview
CorDx, a multi-national biotech organization focused on innovation in global health, seeks a 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 regulatory and safety standards. Job Title
Senior Production Manager Location
Alpharetta, GA (On-site) 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. Qualifications
Minimum of 10 years of experience in production, manufacturing, or operations management At least 5 years of leadership experience, with a proven track record of managing and developing teams Experience overseeing teams of 5 or more direct reports in a manufacturing or production setting Stable employment history, with an average job tenure of at least 30 months per role Industry experience in life sciences, in vitro diagnostics (IVD), or related manufacturing is preferred Relevant certifications in production, operations, or supply chain management (e.g., Six Sigma, PMP, CPIM) are highly desirable Career stability—candidates should have worked at no more than seven companies Proven experience in scaling production operations, improving efficiency, and implementing process improvements Benefits
Highly competitive compensation package Comprehensive medical, dental, and vision insurance 401(k) plan with generous company contributions Flexible paid time off (PTO) policy Additional substantial benefits Equal Opportunity
We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
#J-18808-Ljbffr
CorDx, a multi-national biotech organization focused on innovation in global health, seeks a 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 regulatory and safety standards. Job Title
Senior Production Manager Location
Alpharetta, GA (On-site) 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. Qualifications
Minimum of 10 years of experience in production, manufacturing, or operations management At least 5 years of leadership experience, with a proven track record of managing and developing teams Experience overseeing teams of 5 or more direct reports in a manufacturing or production setting Stable employment history, with an average job tenure of at least 30 months per role Industry experience in life sciences, in vitro diagnostics (IVD), or related manufacturing is preferred Relevant certifications in production, operations, or supply chain management (e.g., Six Sigma, PMP, CPIM) are highly desirable Career stability—candidates should have worked at no more than seven companies Proven experience in scaling production operations, improving efficiency, and implementing process improvements Benefits
Highly competitive compensation package Comprehensive medical, dental, and vision insurance 401(k) plan with generous company contributions Flexible paid time off (PTO) policy Additional substantial benefits Equal Opportunity
We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
#J-18808-Ljbffr