Manufacturing Operations Leader - Medical Devices (GMP/Lean)

Integra LifeSciences; Mansfield (MA); On-site; USD 67,650 - 112,700; Full time

Job summary

Integra LifeSciences in Mansfield, MA seeks a Supervisor, Manufacturing Operations to lead daily production in Machining, Packaging and Boxing while ensuring safety, quality and efficiency across shifts.

The role requires 3+ years of GMP leadership, strong regulatory knowledge and experience with cleanroom gowning. You will drive Lean initiatives, mentor staff and collaborate with QA and Materials Management to optimize throughput.

Qualifications

• Bachelor's degree or higher in Science, Engineering, or related field.
• 3+ years of leadership experience in a GMP regulated environment.
• Knowledge of NCs and CAPAs.
• Strong written and verbal communication; leadership and team-focused.
• Ability to gown into ISO 7 and ISO 5 clean room.
• Batch manufacturing experience.
• Familiarity with FDA, ISO 9001/13485 and related regs.
• Strong computer skills, MS Office.
• Automation experience preferred.
• Oracle R12/Agile knowledge.
• Lean/Six Sigma knowledge a plus.

Responsibilities

• Direct daily production activities and staff in Machining, Packaging, Boxing areas for multiple product lines.
• Meet daily production goals and report progress at shift and tier meetings.
• Operate, maintain, troubleshoot process equipment and make minor adjustments as needed.
• Maintain logs, inventories and place purchase requisitions for processing supplies.
• Lead operations in cleanroom environment with proper environmental controls.
• Support Non-Conformance/CAPA/Audit investigations.
• Ensure compliance with GMP standards and SOPs.
• Lead process improvements and Lean initiatives to boost performance.
• Collaborate with cross-functional teams and mentor staff.
• Perform admin tasks like timecards and training records.
• Interface with QA for inspections and with Materials Management for material flow.
• Promote safety and continuous improvement within the department.
• Work with Manufacturing Engineering to improve yield and reduce scrap.

Skills

Leadership

Communication

GMP

Lean Six Sigma

ISO 9001

Regulatory compliance

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 daily production in Machining, Packaging and Boxing while ensuring safety, quality and efficiency across shifts.

The role requires 3+ years of GMP leadership, strong regulatory knowledge and experience with cleanroom gowning. You will drive Lean initiatives, mentor staff and collaborate with QA and Materials Management to optimize throughput.