Production Manager

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.

Job Title : Production Manager

Location : Alpharetta, GA(On-site)

Reports To : Chief Executive Officer (CEO)

Compensation: $40 per hour (non-exempt)

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.

Requirements

• 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 six companies, with no prior consulting experience.
• Proven experience in scaling production operations, improving efficiency, and implementing process improvements.

Benefits

• Comprehensive health insurance.

• 401(k) plan with company match.
• Paid time off and holiday schedule.
• Opportunities for professional development and career advancement.

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.