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- Aufgaben: Lead the quality management system and ensure compliance with MDR regulations.
- Arbeitgeber: Join a leading medical device company focused on innovation and quality.
- Mitarbeitervorteile: Enjoy opportunities for professional growth and international travel.
- Warum dieser Job: Make a real impact in healthcare while working in a dynamic, ethical environment.
- Gewünschte Qualifikationen: Bachelor’s degree in Life Science and 5+ years in Regulatory or Quality Assurance required.
- Andere Informationen: Must be willing to travel up to 10% for business.
Das voraussichtliche Gehalt liegt zwischen 48000 - 72000 € pro Jahr.
Responsibilities:
- Build and maintain certified MDR Quality Management System
- Lead product registration process with Notified Body
- Represent the QMS as deputy PRRC
- Maintain local training compliance
- Lead and participate in internal audits
- Provide Quality related trainings
- Organize site Management Review
- Track and report KPIs
- Supplier qualification including leading of audits
- Site QARA projects
Skills Required:
- Bachelor’s degree in Life Science or equivalent
- Minimum of 5 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
- Record of success and broad understanding of contemporary quality practices as they apply to product development, manufacturing, and commercial operations
- Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing organization under MDR regulation
- Expertise in MDR, cGMP and other Regulatory compliance requirements
- Experience in software development in the medical device context
- Self-confidence and the ability to work with all levels of organization
- Operates in a way that never compromises ethics and integrity
- Advanced leadership skills
- Ability to understand and adapt to different cultures and market needs
- (Inter-)national travel as required by business (up to 10%)
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QA Engineer MDR Arbeitgeber: Recooty
Kontaktperson:
Recooty HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: QA Engineer MDR
✨Tip Number 1
Familiarize yourself with the latest MDR regulations and compliance requirements. This will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those involved in quality assurance and regulatory affairs. Attend relevant conferences or webinars to make connections that could lead to job opportunities.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully implemented quality processes in previous roles. Highlight your experience with audits and training, as these are key components of the QA Engineer role.
✨Tip Number 4
Showcase your leadership skills by discussing instances where you've led teams or projects. Emphasize your ability to work across different cultures and adapt to various market needs, as this is crucial for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: QA Engineer MDR
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly understand the responsibilities and requirements of the QA Engineer MDR position. Highlight your relevant experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance in your application.
Tailor Your CV: Customize your CV to reflect your expertise in MDR, cGMP, and quality processes in medical device manufacturing. Use specific examples from your past experiences that demonstrate your success in these areas.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your leadership skills and ability to work with diverse teams. Mention your experience with audits and training, as well as your commitment to ethics and integrity.
Highlight Key Achievements: In your application, emphasize key achievements related to quality management systems and product registration processes. Use metrics and KPIs to quantify your successes where possible.
Wie du dich auf ein Vorstellungsgespräch bei Recooty vorbereitest
✨Understand the MDR Landscape
Make sure you have a solid grasp of the Medical Device Regulation (MDR) and its implications for quality management systems. Be prepared to discuss how your experience aligns with these regulations and how you've successfully navigated them in past roles.
✨Showcase Your Quality Management Experience
Highlight your experience in building and maintaining quality management systems. Be ready to provide specific examples of how you've led product registration processes and interacted with Notified Bodies.
✨Demonstrate Leadership Skills
Since the role requires advanced leadership skills, prepare to discuss situations where you've led teams or projects. Emphasize your ability to work with diverse groups and adapt to different cultures.
✨Prepare for Technical Questions
Expect technical questions related to quality assurance practices, regulatory compliance, and supplier qualification. Brush up on your knowledge of cGMP and other relevant standards to confidently answer these questions.
