Manufacturing Ops Supervisor – Medical Devices, GMP

Scorpion Therapeutics

Mansfield (MA)

On-site

USD 110,000 - 150,000

Full time

10 days ago
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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

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.

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