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- Aufgaben: Lead quality management processes and ensure compliance with ISO standards.
- Arbeitgeber: Join a dynamic team in the regulated medical device industry.
- Mitarbeitervorteile: Enjoy professional development opportunities and a collaborative work environment.
- Warum dieser Job: Shape quality processes and drive innovation in a key leadership role.
- Gewünschte Qualifikationen: Degree in natural sciences or engineering; 3+ years in quality management required.
- Andere Informationen: Ideal for those passionate about quality assurance in healthcare.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
Director of Quality & Regulation Affairs
Role Overview:
We are looking for a Quality Management Specialist to oversee and enhance quality management processes in compliance with ISO standards and regulatory requirements. This role involves acting as the key liaison between internal quality teams, ensuring audit readiness, and driving continuous improvement in quality management systems.
Key Responsibilities:
- Serve as the central communication interface between quality management teams and related organisational units.
- Develop and maintain a quality management concept, ensuring alignment with regulatory and company-wide standards.
- Monitor and document quality management processes in compliance with applicable regulations.
- Prepare and maintain audit documentation to meet regulatory requirements.
- Plan and support internal and external audits, ensuring compliance with ISO and medical device regulations.
- Assess quality performance and propose improvements to management.
- Ensure compliance with medical device risk management and reporting obligations.
- Prepare management reports and reviews related to quality performance.
Your Profile:
- Degree in natural sciences, engineering, or a related field.
- Minimum 3 years of experience in quality management, ideally within medical devices or regulated industries.
- Experience with internal and external audits.
- Strong analytical and problem-solving skills.
- Structured working style with the ability to collaborate within teams.
- Ability to work independently while driving innovation and optimisation.
- Strong communication and organisational skills, with a strategic mindset.
What We Offer:
- A key role in quality management within a regulated industry.
- Opportunities to shape and improve quality processes.
- Collaboration with cross-functional teams in a dynamic environment.
- Professional development and growth opportunities.
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries
Software Development and Hospitals and Health Care
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Director of Quality & Regulation Affairs Arbeitgeber: MAM Gruppe
Kontaktperson:
MAM Gruppe HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Director of Quality & Regulation Affairs
✨Tip Number 1
Familiarize yourself with ISO standards and medical device regulations. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the quality management field, especially those who work in regulated industries. Attend industry conferences or webinars to connect with potential colleagues and learn about best practices.
✨Tip Number 3
Prepare to discuss specific examples of how you've driven continuous improvement in quality management systems in your previous roles. Highlight your analytical skills and problem-solving abilities during conversations.
✨Tip Number 4
Showcase your ability to collaborate across teams by discussing past experiences where you acted as a liaison between different departments. This will illustrate your communication skills and strategic mindset.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Director of Quality & Regulation Affairs
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly read the job description for the Director of Quality & Regulation Affairs. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in quality management, particularly within medical devices or regulated industries. Provide specific examples of how you've contributed to quality processes and compliance.
Showcase Your Skills: Make sure to highlight your analytical and problem-solving skills, as well as your ability to work independently and collaboratively. Use concrete examples to demonstrate these skills in action.
Prepare a Strong Cover Letter: Craft a compelling cover letter that outlines your motivation for applying and how your background aligns with the company's goals. Mention your strategic mindset and how you can contribute to continuous improvement in quality management systems.
Wie du dich auf ein Vorstellungsgespräch bei MAM Gruppe vorbereitest
✨Understand ISO Standards
Make sure you have a solid grasp of ISO standards relevant to quality management. Be prepared to discuss how you've applied these standards in your previous roles, especially in the context of medical devices.
✨Showcase Your Audit Experience
Highlight your experience with both internal and external audits. Discuss specific examples where you ensured compliance and how you prepared documentation for audits, as this is crucial for the role.
✨Demonstrate Analytical Skills
Be ready to showcase your analytical and problem-solving skills. Prepare examples of how you've assessed quality performance and proposed improvements in past positions, as this will demonstrate your capability to drive continuous improvement.
✨Communicate Effectively
Since this role involves acting as a liaison between teams, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've collaborated with cross-functional teams to enhance quality management processes.
