Director of Manufacturing
Manufacturing Director
Medical Devices
Cleveland, OH
Start date : ASAP
$125,000 $150,000
Permanent, full time
The Manufacturing Director holds a pivotal position in supervising and enhancing manufacturing procedures for Class III In vitro Diagnostics, ensuring that resources, equipment, and facilities are efficiently utilized to meet production demands essential for business operations.
Responsible for upholding compliance with cGMP and ISO standards and oversees the effectiveness of the production process.
Responsibilities :
- Develop and implement plans and resource allocations to meet production requirements as per business demands.
- the production process to ensure compliance with regulatory reporting standards and facilitate product recalls if necessary.
- and adhere to departmental budgets.
- efficiency enhancements and cost-saving measures aligned with corporate objectives.
- utilize manufacturing software systems like MRP, MES, SPC, and Compliance tools.
- compliance with FDA, ISO, and Quality System requirements, as well as safety standards.
- manufacturing-related audit findings, non-conformances, corrective / preventive actions, or customer complaints.
- robust manufacturing and kitting platforms for In vitro diagnostic reagents and controls.
- continuous improvement initiatives to boost operational efficiency and productivity. Identify opportunities for process optimization, automation, and cost reduction while maintaining quality and compliance standards.
- relationships with supply chain partners, including third-party contract manufacturers, to optimize raw material sourcing, procurement, and inventory management.
- timely availability of materials to support production schedules and minimize supply chain disruptions.
- statistical methods and data analysis tools to identify trends, deviations, and opportunities for optimization and improvement.
Basic Qualifications :
- degree in chemistry, biochemistry, or a related field + 10-20 years of experience in manufacturing Class III In Vitro Diagnostics (IVD), with a preference for experience in reagent manufacturing.
- years of management experience.
- familiarity with FDA regulations (e.g., 21 CFR 820) and ISO standards (e.g., ISO 13485).
- in Design Control.
- in process validation and statistical process control.
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