What are the responsibilities and job description for the Production Manager position at CorDx?
About Us
CorDx is a leading healthcare diagnostic manufacturer dedicated to delivering high-quality diagnostic solutions to consumers and healthcare professionals. Our commitment to innovation and excellence drives us to improve our products and services.
We are seeking an experienced 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.
CorDx is a leading healthcare diagnostic manufacturer dedicated to delivering high-quality diagnostic solutions to consumers and healthcare professionals. Our commitment to innovation and excellence drives us to improve our products and services.
We are seeking an experienced 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
- Bachelor's degree in Manufacturing, Engineering, Industrial Management, or a related field
- 5 years of experience in a manufacturing leadership role, preferably in the medical device industry
- Strong knowledge of ISO 13485, FDA regulations, and GMP requirements
- Experience with Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies
- Proven ability to lead teams, drive performance, and implement process improvements
- Excellent problem-solving, organizational, and communication skills
- Proficiency in NetSuite ERP/MRP systems and production planning tools
- Comprehensive health insurance
- 401(k) plan with company match
- Paid time off and holiday schedule
- Opportunities for professional development and career advancement
