Supervisor, Manufacturing Operations

Scorpion Therapeutics; Mansfield (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Integra's Mansfield, MA facility seeks a Supervisor of Manufacturing Operations to oversee neurosurgical medical devices production. You will direct daily activities across Machining, Packaging, and Boxing, ensure safety, quality, delivery, and cost targets, and lead improvements with QA, Engineering, and Product Development.

The role requires a Bachelor’s degree in a relevant field, 3+ years GMP leadership, and strong communication/leadership skills.

Qualifications

• Bachelor's degree in Science, Engineering, or related field preferred.
• 3+ years leadership in GMP environment.
• Knowledge of FDA regulations, ISO 9001/13485.
• Experience with batch manufacturing, NCs, CAPAs.
• Strong communication and leadership skills.
• Gowning into ISO 7/5 clean room.
• Computer proficiency including Microsoft Office.
• Automation and Oracle R12/Agile experience a plus.
• Understanding of Lean/Six Sigma desirable.

Responsibilities

• Direct daily manufacturing activities across Machining, Packaging, and Boxing, ensuring safety, quality, delivery, and cost targets.
• Operate and troubleshoot process equipment.
• Maintain compliance with GMP, FDA, ISO standards.
• Lead process improvements and lean initiatives.
• Manage staff performance, training, and safety culture.
• Coordinate with QA, Materials Management, Engineering, and Product Development.

Skills

FDA regulations

ISO 9001/13485

Batch manufacturing

Nonconformances (NCs)

CAPAs

Communication

Leadership

Cleanroom gowning

MS Office

Automation

Oracle R12

Agile

Lean/Six Sigma

Education

Bachelor's degree in Science/Engineering or related field

Job description

Role

Supervisor of Manufacturing Operations at Integra's Mansfield, MA facility, overseeing production of neurosurgical medical devices.

Responsibilities

• direct daily manufacturing activities across Machining, Packaging, and Boxing, ensuring safety, quality, delivery, and cost targets
• operate and troubleshoot process equipment
• maintain compliance with GMP, FDA, ISO standards
• lead process improvements and lean initiatives
• manage staff performance, training, and safety culture
• coordinate with QA, Materials Management, Engineering, and Product Development

Requirements

• Bachelor's degree in Science, Engineering, or related field preferred
• 3+ years leadership in GMP environment
• knowledge of FDA regulations, ISO 9001/13485
• experience with batch manufacturing, NCs, CAPAs
• strong communication and leadership skills
• gowning into ISO 7/5 clean room
• computer proficiency including Microsoft Office
• automation and Oracle R12/Agile experience a plus
• understanding of Lean/Six Sigma desirable

High-Value

• Medical device manufacturing
• Neurosurgical applications
• GxP compliance
• GMP
• ISO
• cleanroom environment
• process troubleshooting
• continuous improvement
• team leadership

WorkSetup

on-site in Mansfield, MA; no travel specified.