Senior Production Manager

About Us

Cor Dx, 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, Cor Dx 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. Cor Dx 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.

Job Title
:
Senior Production Manager Location
:
Alpharetta, GA?(On-site)

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.

• 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.

• 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.

• 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.

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.