• Manage inventory planning to ensure uninterrupted supply of finished goods.
• Manage CMOs and OEM manufacturers for routine production. Coordinate investigation and trouble-shooting for CMO manufacturing processes.
• Primary responsibility for Quality Control of IncellDx products, including testing, review and approval of test records, and maintenance of QC materials inventory.
• Represent manufacturing department during design control activities and design reviews for new products.
• Document and revise manufacturing and quality control procedures, establish sampling plan rationale; collaborate with Product Development to document material specifications and oversee accurate transfer of product Design to Manufacturing.
• Conduct technical studies to support manufacturing, quality control and product development; investigate non-conformances, solve product-related technical problems and troubleshoot as needed; document and approve results in Non-Conformance Reports, Corrective Action Reports and/or Technical Reports.
• Ensure proper receiving, labeling and location of materials in accordance with company SOPs; track product inventory levels, provide monthly inventory report to COO and investigate inventory discrepancies with accounting.
• Supervise and perform internal manufacturing procedures e.g product labeling and assembly.
• Trend quality control and product performance results as input to Management Review
• Participate in Risk Analysis of manufacturing processes using FMEA.
• Supervise Stability Study Program to establish product shelf life and transport methods.
• Work cross-functionally as needed to support all company and department objectives
• Act as back-up for shipping and invoicing activities; perform check entry into QuickBooks
• Manage one direct report.
Work conditions and physical requirements
• The work is performed indoors, in a general office environment and in a biology laboratory.
• Some tasks require the ability to work for extended periods of time on a computer.
• Some tasks require the ability to work for extended periods of time at the lab bench, performing complex, repetitive manual tasks and detailed visual observations.
• Some tasks require the use of hazardous and/or toxic chemicals and potentially hazardous biological materials.
• Some tasks require the ability to lift up to 40lbs.
• Some tasks require the ability to climb on mobile platform ladder.
• On-call duties for temperature monitoring of equipment.
• Must be able to read, write, and communicate fluently in English.
• MS plus 2-5 years related work experience in Medical Device Manufacturing
• Experience working in FDA QSR/ISO 13485, 9001 regulated environment
• Highly detail-oriented yet flexible
• Comfortable in a quick paced environment; able to shift priorities when needed
• Excellent written and verbal communications skills
• Flow cytometry experience is a plus
• Cell culture experience is a plus