Logo of Huzzle

Home

Matches

Explore

Manage

Drug Delivery Devices Quality Lead Expert (all genders)

image

Merck Group

22d ago

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Zürich

AI generated summary

  • You must have a Master's, PhD, or MD in a science field, extensive Quality experience in medical devices, knowledge of ISO 13485, 21 CFR 820, and fluency in English.
  • You will ensure quality compliance in drug delivery device projects, oversee documentation and regulatory submissions, manage supplier qualifications, and handle post-market surveillance and compliance processes.

Requirements

  • 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. Other languages are an asset
  • Ability to work on concurrent projects with a sense of ownership

Responsibilities

  • 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.

FAQs

What is the primary focus of the Drug Delivery Devices Quality Lead Expert role?

The primary focus is to act as the quality management representative in development projects for delivery systems for injectable drugs, ensuring compliance with quality and regulatory requirements.

What qualifications are required for this position?

A Master’s, PhD, or MD degree in science or a related field is required, along with several years of experience in Quality, ideally in the field of medical devices.

What key regulations should candidates be knowledgeable about?

Candidates should have excellent knowledge of ISO 13485, 21 CFR 820, ISO 14971, medical device regulations, CE marking, and 510(k) for combination products.

Is proficiency in languages other than English beneficial?

Yes, proficiency in other languages is considered an asset.

What is the expected working environment for this role?

The role is part of a diverse, inclusive, and flexible working culture, supporting personal development and career advancement opportunities across the globe.

Will I be required to lead supplier qualifications?

Yes, the role includes leading the qualification and monitoring of suppliers.

What responsibilities will I have in relation to marketed medical devices?

You will ensure compliance in deviation and complaint handling processes, lead corrective and preventive action processes, perform quality/regulatory assessments of changes, and supervise the change control process.

Are there opportunities for personal development within the organization?

Yes, there are great opportunities for personal development and career advancement within the organization.

How does the company view diversity and inclusion?

The company celebrates all dimensions of diversity, believing that it drives excellence and innovation, and is committed to creating access and opportunities for all employees to develop and grow.

What types of projects will I work on?

You will work on concurrent projects related to the quality management of drug delivery devices and injectable drugs, including clinical evaluations and regulatory submissions.

image

Merck Group

We are Merck, a vibrant science and technology company. Science is at the heart of everything we do.

Manufacturing & Electronics
Industry
10,001+
Employees
1668
Founded Year

Mission & Purpose

This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada. _______________________________ We are Merck, a leading global science and technology company headquartered in Germany. We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet. We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength. We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. Work your Magic and join Merck