Quality Project Manager

SCHERDEL Medtec North America LLC., located in Muskegon, MI, is a subsidiary of SCHERDEL GmbH, a family-managed company with sales and manufacturing activities at 42 sites across Europe, North and South America, and Asia. We are strongly value-driven with a long track record of caring for our associates.

About the role

The Quality Project Manager coordinates customer projects within the organization and supports Operations Quality requirements to meet our Quality Management objectives.

Responsibilities

• Serve as the primary quality contact for customers throughout project execution.
• Lead qualification, validation, and quality planning activities for new product launches.
• Develop, maintain, and train employees on quality procedures and SOPs.
• Support manufacturing teams in maintaining compliance with quality and validation requirements.
• Support production plants in maintaining the validated status.
• Coordinate internal, customer, and certification audits and drive continuous improvement of the Quality Management System.
• Lead cross-functional project teams to ensure successful execution, on-time delivery, and adherence to quality standards.
• Identify and mitigate project risks related to quality, timing, and customer requirements.
• Support RFQs, feasibility reviews, customer documentation, and project reporting while promoting SCHERDEL's capabilities and value proposition.

Requirements

• Bachelor's degree in Engineering, Quality, Manufacturing, Biomedical Engineering, or a related technical field.
• 3+ years of experience in Quality Engineering, Quality Project Management, or Manufacturing Engineering.
• Experience in a regulated industry, preferably Medical Devices (ISO 13485), Healthcare, Pharmaceutical, or Automotive.
• Proven experience leading cross-functional projects from launch through validation and production.
• Knowledge of quality tools and methodologies such as FMEA, CAPA, Root Cause Analysis, and Risk Management.
• Strong project management, communication, and customer-facing skills.
• Experience with qualification and validation activities (IQ/OQ/PQ).
• PMP, ASQ, Lean Six Sigma, or similar certifications are a plus.
• Ability to travel domestically and internationally as required.

Skills

• Self-directed
• Analytical and process-oriented thinking
• Excellent communication and documentation skills
• Excellent eye for detail
• Ability to manage multiple customers simultaneously and prioritize tasks
• Works well individually as well as in a team environment

Competencies

• Time Management
• Results Driven
• Problem Solver
• Thoroughness
• Communication
• Personal Effectiveness/Credibility