Job Description

Production / Operations Manager - Medical Devices

Department:

Operations / Manufacturing

Reports To:

Director of Operations / Plant Manager

Job Summary

The Production / Operations Manager is responsible for overseeing daily manufacturing operations of medical devices to ensure products are produced safely, efficiently, and in full compliance with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP). This role leads production teams, drives continuous improvement, and ensures quality, delivery, and cost objectives are met.

Key Responsibilities Production & Operations

Plan, schedule, and manage daily production activities to meet demand forecasts Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, and GMP requirements Monitor production output, yields, scrap, and rework Optimize processes to improve efficiency and reduce waste Coordinate cross-functionally with Quality, Engineering, Supply Chain, and Regulatory teams

Quality & Compliance

Ensure adherence to approved procedures, work instructions, and device master records (DMRs) Support audits and inspections (FDA, notified bodies, internal audits) Ensure proper documentation, batch records, and traceability Lead investigations and corrective actions (CAPA, deviations, nonconformances)

People Management

Lead, train, and develop production supervisors and operators Ensure adequate staffing, training, and competency per regulatory requirements Promote a culture of quality, safety, and continuous improvement

Safety & Risk Management

Ensure compliance with EHS regulations and company safety policies Identify and mitigate operational risks that could impact product quality or patient safety

Continuous Improvement

Lead Lean Manufacturing, Six Sigma, or Kaizen initiatives Improve OEE, cycle time, and throughput Implement automation or process improvements in collaboration with Engineering

Qualifications Education

Bachelor's degree in Engineering, Operations Management, Manufacturing, or related field

Experience

5+ years of manufacturing or operations experience in

medical devices or regulated industries

3+ years in a leadership or supervisory role Hands-on experience with FDA QSR, ISO 13485, GMP

Skills & Competencies

Strong understanding of medical device regulations Experience with ERP/MRP systems Excellent leadership and communication skills Data-driven decision-making and KPI management Root cause analysis and CAPA experience

Key Performance Indicators (KPIs)

Regulatory compliance and audit outcomes On-time delivery and production efficiency Yield, scrap, and rework rates CAPA closure effectiveness Safety metrics

Preferred Qualifications

Lean Six Sigma certification Experience with Class II or Class III medical devices Experience with cleanroom manufacturing
Job Type: Full-time

Pay: ?3,500,000.00 - ?5,000,000.00 per month

Benefits:

Flexible schedule Health insurance Life insurance Paid sick time Provident Fund
Work Location: In person