Lead Manufacturing Operations Supervisor - Medical Devices

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences in Mansfield, MA seeks a Supervisor, Manufacturing Operations to lead all activities in the manufacturing area. You will supervise production personnel to maximize safety, quality, delivery, cost and engagement while achieving targets and controlling costs.

Responsibilities include directing daily production in Machining, Packaging, and Boxing, maintaining logs, and leading cleanroom operations with regulatory compliance.

Qualifications

• Bachelor’s degree or higher in Science, Engineering, or related field; leadership in regulated environments.
• 3+ years of leadership experience in a GMP regulated industry.
• Knowledge of NCs and CAPAs.
• Strong written and verbal communication skills.
• Gowning into ISO 7 and ISO 5 Clean Room.
• Batch manufacturing experience.
• Familiarity with FDA regulations, ISO 9001/13485, and other regulations.
• Lean/Six Sigma knowledge a plus.

Responsibilities

• Direct daily production activities and staff in Machining, Packaging, Boxing for multiple product lines.
• Ensure daily production goals are met and report progress in meetings.
• Operate, maintain, troubleshoot, and adjust process equipment.
• Maintain logs and records for WIP activities.
• Maintain process and component inventories and place requisitions.
• Lead operations in cleanroom environment and ensure environmental controls.
• Support Non-Conformance/CAPA/Audit investigations.
• Ensure compliance with GMP, QSRs, SOPs and safety requirements.
• Lead process improvements and Lean initiatives to improve performance.
• Collaborate with cross-functional teams and coach staff.

Skills

Leadership

Communication

Gowning into ISO cleanroom

GMP knowledge

Lean/Six Sigma

Education

Bachelor’s degree or higher in Science/Engineering

Tools

Oracle R12/Agile

Microsoft Office

Job description

Integra LifeSciences in Mansfield, MA seeks a Supervisor, Manufacturing Operations to lead all activities in the manufacturing area. You will supervise production personnel to maximize safety, quality, delivery, cost and engagement while achieving targets and controlling costs.

Responsibilities include directing daily production in Machining, Packaging, and Boxing, maintaining logs, and leading cleanroom operations with regulatory compliance.