Finde einen Job 
Finde eine Ausbildung 
Top Arbeitgeber 
Top Universitäten 
Für Unternehmen Auf einen Blick
- Aufgaben: Lead quality management for drug delivery device projects and ensure compliance with regulations.
- Arbeitgeber: Join a leading company in the medical devices sector, focused on innovation and quality.
- Mitarbeitervorteile: Enjoy a dynamic work environment with opportunities for growth and global impact.
- Warum dieser Job: Be at the forefront of healthcare innovation while ensuring patient safety and product excellence.
- Gewünschte Qualifikationen: Master's, PhD, or MD required; experience in Quality and medical devices is essential.
- Andere Informationen: Fluency in English is a must; additional languages are a plus.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
Role level 3, in Drug Devices Quality & Regulatory department, based in Eysins.
Your role:
Act as quality management representative in development projects for delivery systems for injectable drugs:
Ensure design control compliance. Identify applicable quality and regulatory requirements.
Review and approve all project deliverables. Review and approve labelling material. Participate to design reviews.
Compile the Technical Documentation, ensure CE mark approval. Lead the clinical evaluation effort, in collaboration with the medical team.
Support regulatory submission worldwide.
Lead the qualification and monitoring of suppliers.
Act as quality management representative for the maintenance of marketed medical devices:
Ensure compliance of the deviation and complaint handling processes. Lead the corrective and preventive action process. Perform the quality/regulatory assessment of proposed changes. Supervise the change control process.
Ensure continued compliance to new or revised regulations and standards.
Lead the post-market surveillance effort, in collaboration with the safety and complaint teams.Support regulatory submissions/renewals worldwide
Who you are
- Master, PhD or MD degree in science or related field
- Several years of experience in Quality, ideally in the field of medical devices
- Excellent knowledge of ISO 13485, 21 CFR 820, ISO 14971
- Excellent knowledge of medical device regulations, CE marking, 510 (k); 21 CFR 4 for combination products
- Fluent in English. Otherlanguages are an asset
- Ability to work on concurrent projects with a sense of ownership
#J-18808-Ljbffr
Drug Delivery Devices Quality Lead Expert (all genders) Arbeitgeber: Merck Gruppe
Kontaktperson:
Merck Gruppe HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Drug Delivery Devices Quality Lead Expert (all genders)
✨Tip Number 1
Familiarize yourself with the specific quality management systems and regulatory frameworks relevant to drug delivery devices. Understanding ISO 13485 and 21 CFR 820 in depth will give you a significant advantage during interviews.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality management. Engaging in discussions about current trends and challenges can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest changes in medical device regulations and standards. Being able to discuss recent developments during your interview will demonstrate your commitment to the field and your proactive approach.
✨Tip Number 4
Prepare to showcase your experience with concurrent projects and your sense of ownership. Be ready to share specific examples of how you've successfully managed multiple responsibilities while ensuring compliance and quality.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Drug Delivery Devices Quality Lead Expert (all genders)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Drug Delivery Devices Quality Lead Expert position. Understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in quality management, particularly in the medical devices sector. Mention specific projects where you ensured compliance with ISO 13485 or similar regulations.
Showcase Technical Knowledge: Demonstrate your knowledge of relevant regulations and standards such as 21 CFR 820 and ISO 14971. Use specific examples from your past work to illustrate your expertise in these areas.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the role. Discuss your ability to lead projects, manage compliance, and collaborate with cross-functional teams, as these are crucial for the position.
Wie du dich auf ein Vorstellungsgespräch bei Merck Gruppe vorbereitest
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of ISO 13485, 21 CFR 820, and ISO 14971 during the interview. Be prepared to discuss how you've applied these regulations in past projects, as this will demonstrate your expertise in quality management for medical devices.
✨Discuss Your Experience with Design Control
Since the role involves ensuring design control compliance, be ready to share specific examples of how you've managed design controls in previous roles. This could include your involvement in design reviews or how you ensured project deliverables met quality standards.
✨Emphasize Your Project Management Skills
The ability to work on concurrent projects is crucial for this position. Talk about your experience managing multiple projects simultaneously, focusing on how you maintained quality and compliance while meeting deadlines.
✨Prepare for Questions on Supplier Management
As supplier qualification and monitoring are key responsibilities, prepare to discuss your experience in this area. Be ready to explain how you've assessed suppliers and ensured they meet regulatory requirements, as well as any challenges you've faced and how you overcame them.
