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Quality Management Representative

Yardley, Pensilvania

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ID de la oferta 58587 Functional area __L10N__:Quality Assurance Full-time/part-time __L10N__:Full Time Experience level Professional

Quality Management Representative

[title]
Quality Management Representative
Permanent 

About Heraeus Medical

Restore mobility from severe osteoarthritis or bone disease? Improving surgical outcomes with bone cement? Heraeus Medical offers advanced solutions from orthopedics to infection management. Excellent quality drives us and brings joy back – into the lives of patients and into your work. What about you? Play in the top league of medical technology at Heraeus Medical.

Heraeus Medical, headquartered in Wehrheim (Germany), is an Operating Company of the Heraeus Group. The Technology Group delivers world-class quality in the areas of Metals & Recycling, Healthcare, Semiconductor & Electronics and Industrials. As one of the top 10 family-owned companies in Germany, Heraeus employs around 15,200 employees in 40 countries.

The following challenges await you:

  • 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.

Your Profile:

  • 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

Curious? Apply now!

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.   

We participate in E-Verify to confirm employment eligibility after hire. Learn more at www.e-verify.gov


Any further questions?

If you need any assistance or have questions, please contact hrdirect-americas@heraeus.com or visit our website at jobs.heraeus.com.


ReqID: 58587
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