Medical Device Complaint Coordinator (f/m/d)
About the role: Are you passionate about ensuring the highest standards of quality and safety in the healthcare industry? Do you possess excellent organizational skills and thrive in a dynamic, fast-paced environment? If so, we have an exciting opportunity for you! As a Medical Device Complaint Coordinator (f/m/d), you will play a vital role in our quality assurance team, responsible for managing and coordinating the complaint handling process for our medical devices.
This position will be located at our facility in Putzbrunn near Munich, Germany, with work from home days possible as part of a hybrid arrangement, depending upon the responsibilities of the role and business needs.
Responsibilities:
- Recording, evaluating and investigating customer complaints related to our medical products
- Collaborating with cross-functional teams (field service, regulatory and clinical departments, product specialists) to ensure timely and thorough investigations
- Communicating with Field Sales and customers to elaborate complaint cases
- Maintaining accurate records and documentation in compliance with regulatory requirements using our Complaint Management System
- Ensure timely Manufacturer Incident and Medical Device Reporting as required per EU MDR and FDA regulations
- Identifying trends or potential issues and support the implementation of corrective actions to prevent recurrence
- Serving as a point of contact for internal stakeholders and regulatory agencies regarding complaint investigations
- Ensuring compliance with quality standards and legal requirements in complaint processing
Required Qualifications:
- At least 1 year of professional experience in the medical device industry and a Bachelor's degree in a related disciplines or clinical professionals, who are looking for a career change into the industry
- Excellent communication and interpersonal skills
- Exceptional organizational abilities with a keen attention to detail
- Ability to work effectively both independently and as part of a team
- Experience in medical device quality, regulatory (e.g., FDA, ISO 13485) and clinical knowledge is an advantage
- Very good written and spoken communication skills in English and German
- Confident use of MS Office tools
- Occasional travelling e.g. trainings, meetings (up to 5%)
Desired Qualifications:
- Proven experience in supporting audits or regulatory response communications with successful outcomes
- Professional experience in medical coding or a related field
- Experience with the SmartSolve Complaint Management System
Remote Working Arrangements are permitted for Associates, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed.
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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About Gore
For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.