Director, Combination Product & Device Pqm

Johnson & Johnson MedTech

Horsham, Pennsylvania, United States of America
Base: $150,000.00 - $258,750.00; bonus/equity: eli...
Hybrid
Combination product quality engineering
Design control and risk management
Quality systems and compliance
Johnson & Johnson MedTech is seeking a Director for Combination Product & Device Product Quality Management, responsible for overseeing quality engineering and assurance for drug-device combination products. The ideal candidate will possess extensive experience in the pharmaceutical and medical device industries, focusing on compliance and quality management

Job Summary

  • The Director, Combination Product & Device, PQM provides Quality Engineering & Quality Assurance leadership for a dynamic portfolio of Drug-Device combination products in J&J Innovative Medicine.
  • This role involves providing strategic direction for combination product development initiatives and ensuring compliance with global regulatory frameworks such as 21 CFR Part 4, FDA QMSR, and EU-MDR.
  • Employees are eligible for comprehensive benefits including retirement plans, long-term incentives, vacation, sick time, parental leave, and volunteer leave.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Director for Combination Product & Device Product Quality Management, responsible for overseeing quality engineering and assurance for drug-device combination products. The ideal candidate will possess extensive experience in the pharmaceutical and medical device industries, focusing on compliance and quality management.

Salary

Base: $150,000.00 - $258,750.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Retirement plans, vacation, sick time, parental leave, and more

Skills & Requirements

Must-have

  • Combination Product Quality Engineering
  • Design Control and Risk Management
  • Quality Systems and Compliance
  • Stakeholder Management
  • Project Management and Communication
  • Regulatory Inspection Readiness

Nice-to-have

  • Inclusive Leadership
  • Coaching and Developing Others
  • Fact-Based Decision Making
  • Conflict Management and Facilitation
  • Advanced Quantitative Analysis
  • Lean Supply Chain Management

Key Requirements

  • Bachelor’s degree in scientific or technical discipline
  • Master’s or PhD preferred
  • At least 15 years of industry experience
  • Experience with ISO 13485, ISO 14971, EN 62366, cGMP, ICH requirements
  • Fluent English
  • Strong leadership and decision-making skills

Work Rights

Not specified

Tailored Resume

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