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About Us
CorDx is a multi-national biotech organization focused on innovation and supply in global health. With over 2000 employees serving millions across more than 100 countries, we deliver rapid testing and point-of-care medical devices for infectious diseases like COVID-19, pregnancy, drug abuse, and biomarkers. We are at the forefront of technology, artificial intelligence, and data science, aiming to provide critical healthcare diagnostic solutions.
Job Title: Senior Production Manager
Location: Alpharetta, GA (On-site)
We seek an experienced Senior Production Manager to oversee manufacturing operations in a regulated environment, ensuring compliance with ISO 13485 . The ideal candidate will have a strong background in production management within the medical device or healthcare manufacturing industry , focusing on efficiency, quality, and continuous improvement while maintaining regulatory and safety standards.
Responsibilities
- Production Oversight: Manage daily manufacturing operations, meet production schedules, and uphold high-quality standards.
- ISO 13485 Compliance: Ensure manufacturing processes meet ISO 13485 and regulatory requirements.
- Quality & Process Improvement: Collaborate with QA teams to implement GMP and continuous improvement initiatives.
- Regulatory Compliance: Maintain documentation, procedures, and risk management in line with FDA and ISO standards.
- Team Leadership: Supervise and mentor production staff, fostering safety, accountability, and growth.
- Lean Manufacturing: Apply Lean, Six Sigma, and other techniques to optimize processes.
- Equipment & Maintenance: Oversee maintenance and validation of production equipment.
- Supply Chain Coordination: Work with procurement, logistics, and engineering to ensure material availability.
- Root Cause Analysis: Investigate issues, implement CAPAs, and ensure risk management compliance.
Requirements
- Minimum 10 years in production, manufacturing, or operations management.
- At least 5 years of leadership experience managing teams.
- Experience overseeing teams of 5+ in a manufacturing setting.
- Stable employment history, averaging at least 30 months per role.
- Industry experience in life sciences, IVD, or related manufacturing preferred.
- Certifications like Six Sigma, PMP, or CPIM are highly desirable.
- Proven ability to scale operations and improve efficiency.
Benefits
- Competitive compensation
- Medical, dental, and vision insurance
- 401(k) with company contributions
- Flexible PTO policy
- Additional benefits
Equal Opportunity Statement: We are committed to inclusion and diversity, and do not discriminate based on race, gender, religion, sexual orientation, age, or other protected characteristics.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Other
Industries
- IT Services and IT Consulting
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