Manufacturing Engineering Manager

Coastal Search Associates, LLC; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Clinical Medical Device Company in RTP, NC seeks a Manufacturing Engineering Manager to oversee two contract manufacturers for clinical and post-market devices. The role is local to RTP, NC and requires FDA QMSR/ISO 13485 experience.

You will manage BOMs, supplier data, work orders, and ensure quality systems procedures are followed across manufacturing and release of batches.

Qualifications

• 5–10 years of experience in the medical device field.
• Experience with inventory management systems, e.g., Fishbowl.
• Experience with quality management systems in regulated manufacturing.
• Familiar with FDA QMSR and ISO 13485.
• Experience with durable electromechanical medical devices and software.
• Calibration and validation of equipment/processes in manufacturing.

Responsibilities

• Manage and maintain components, bills of materials, and supplier entries.
• Issue work orders, purchase orders, and ship orders/sales orders.
• Ensure purchases comply with Approved Supplier List and quality procedures.
• Oversee shipping/receiving and maintain FIFO and inventory controls.
• Manage manufacturing and product release with proper batch records.

Skills

Medical device industry experience

Inventory management systems

Quality management systems

Regulatory compliance (FDA QMSR / ISO

Tools

Fishbowl Inventory

Job description

Clinical Medical Device Company, focused on a cutting-edge breakthrough in Cardiovascular Medicine, is located in RTP, NC

Manufacturing Engineering Manager

MUST BE LOCAL to RTP, NC

Authorized to work in the US w/o sponsorship

Medical Device manufacturing experience is REQUIRED

About the Role

Manage two (2) contract Manufacturers. Contract manufacturers produce both clinical and post-market products.

Responsibilities

• Manage and maintain components, bills of materials, and supplier entries in the Inventory Management system. Issue work orders, purchase orders, and ship orders/sales orders.
• Ensure all purchases comply with the Approved Supplier List (ASL) and associated quality system procedures.
• Manage the shipping and receiving functions and ensure that functions are performed in accordance with quality system procedures. Ensure that FIFO is maintained and that inventory locations and storage are controlled.
• Manage the manufacturing and product release functions. Ensure that batch records are maintained in accordance with procedures

Qualifications

• 5-10 years of experience in the medical device field. Familiar with a variety of the field's concepts, practices, procedures, and regulations.
• Experience with low- to mid-level inventory management systems such as Fishbowl.
• Experience working within quality management systems and regulated manufacturing environments.
• Requires experience in the application of FDA’s Quality Management System Regulation and ISO 13485.
• ISO 13485 and FDA (Food and Drug Administration) QMSR experience.
• Experience with durable electromechanical medical devices and devices containing software.
• Experience with equipment calibration and equipment/process validation for medical device manufacturing.