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.
ResponsibilitiesProduction Oversight: Manage daily manufacturing operations, ensuring production schedules are met while maintaining high-quality standards.
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ISO 13485 Compliance: Ensure manufacturing processes comply with
ISO 13485 and regulatory requirements for medical device production.
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Quality & Process Improvement: Work closely with Quality Assurance teams to implement and maintain
Good Manufacturing Practices (GMP) and
continuous improvement initiatives.
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Regulatory Compliance: Ensure documentation, production procedures, and risk management align with
FDA and ISO 13485 guidelines.
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Team Leadership: Supervise and mentor production staff, fostering a culture of safety, accountability, and professional growth.
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Lean Manufacturing: Utilize
Lean, Six Sigma, and other process optimization techniques to enhance efficiency, reduce waste, and improve productivity.
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Equipment & Maintenance: Oversee the maintenance and validation of production equipment to ensure compliance with quality and safety standards.
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Supply Chain Coordination: Collaborate with procurement, logistics, and engineering teams to optimize material availability and minimize downtime.
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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 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.
