Heraeus · 2 months ago
Quality Management Representative
Yardley, PA
Full-time
Onsite
Mid Level
$100K/yr - $115K/yr
3+ years expHeraeus Medical is a leading company in the medical technology sector, focused on providing advanced solutions for orthopedic and infection management. The Quality Management Representative will ensure compliance with quality management system processes, report on system effectiveness, and oversee regulatory compliance for medical devices.
Advanced MaterialsElectronicsHardwareManufacturingPrecious MetalsSustainability
Responsibilities
Ensure that the processes required for the quality management system are documented and continuously comply with the legal requirements of 21 CFR Part 820, 21 CFR 803 and ISO 13485:2016
Report to top management on the effectiveness of the quality management system and any need for improvement, and ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, and to execute such control
Ensure that Heraeus Medical products comply with the legal requirements of 21 CFR Part 820 and ISO 13485:2016 requirements
Perform operational control of necessary immediate, corrective, and preventive actions regarding supplier notifications and internal deviations
Carrying out Medical Device Reporting in accordance with 21 CFR 803
Managing CMO manufacturing
Ensure Regulatory Compliance for Heraeus Medical LLC and its Products
Support for all procurement functions, initiatives to enhance sourcing efficiency, and supplier management
General administrative tasks and handling of routine correspondence related to vendors
Report to management on the effectiveness of the procurement process according to the procurement guidelines
Qualification
Required
Bachelor's Degree (Business or Biology preferred) and at least 3 years of experience in FDA quality systems for medical devices
Demonstrate a high level of integrity, professionalism, and leadership ability; exhibit a high level of motivation and initiative with the ability to meet deadlines
Coaching skills, Project Management, Strategic thinker, Diplomacy skills, ability to work against resistance and take unpopular decisions
Strong oral and written communication skills
Strong organizational and time management skills
Ability to build and maintain good working relationships with employees, managers and external stakeholders
Able to work independently, exercise discretion, prioritize and multi-task in a dynamic environment
The ability to travel up to 20%
Regulatory background for medical devices class I to III desirable
The equivalent combination of education and experience will also be considered
Company
Heraeus
Heraeus is a holding company that produces precious metals, materials and technologies.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Rolf Wetzel
Group CFO
Christine Asher, SHRM-CP
Human Resources Business Partner
Recent News
2026-01-23
ClimateHack Weekly
2025-11-22
Company data provided by crunchbase