What are the responsibilities and job description for the Quality Project Manager - Scherdel Medtec position at SCHERDEL North America?
About the Company
For over 130 years we have been setting standards in the processing of metallic wire and strip as a medium-sized, owner-managed family business, according to our principle “Progress based on tradition “. Today, the Scherdel group has 34 locations worldwide, covering a wide range of areas from forming technology and assembly and joining technology to surface technology and machine, tool, and plant engineering. Building on our deep engineering heritage, our rapidly growing Medtec division delivers specialized, high-precision components (such as specialized springs and stampings) for critical medical device applications.
About the Role
The Quality Project Manager, for our new Medtec N.A. division, is responsible for coordinating customer projects within the organization as well as support Operations Quality requirements to meet our Quality Management requirements and 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.
- 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.
Qualifications
- 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.
Scherdel Sales & Technology, Inc. is an Equal Opportunity Employer (EEO)