Device Quality Manager- On Market

6 months ago

Gaithersburg, United States AstraZeneca Full time

Join us as a Device Quality Manager, where you will provide specialist quality leadership and support for commercialized Combination Products and Medical Devices. This role offers the opportunity to work with internal and external partners, providing portfolio-level device quality support. As a key member of our Operations team, you will be responsible for leading quality planning and improvement activities, partnering with sites and global functions, and influencing at multiple levels of the organization to ensure our device products remain in compliance with the applicable regulations.

Accountabilities:

As a Device Quality Manager, you will provide Device Quality support to Device Technical Leads of above-site / multi-site Combination Products and Medical Devices. You will also provide Device Quality support for above-site / multi-site change assessments for Combination Products and Medical Devices, defining quality strategies, priorities, and plans as required for evaluation activities. Your role will involve supporting Supplier Quality Managers by providing Device Quality expertise to address risk management, change control, quality or auditing activities. You will also lead or support above-site / multi-product responses to Device-related issues to ensure a coordinated and consistent approach.

Essential Skills/Experience:

- BS and/or MS in engineering or equivalent technical discipline

- Five (5) years or more of experience of Combination Products and/or Medical Devices, ideally in a Post-Production (Operations) setting.

- Extensive knowledge of both US and International device requirements (specifically 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC).

- Understanding of the overall drug and device development and commercialization process from development, launch and through life cycle management.

- A good technical knowledge of one of the key portfolio technology areas (parenteral, inhalation, software).

- Evidence of excellent communication skills and building excellent relationships with internal and external customers.

- Project management skills with a track record of successful delivery within a matrix organization.

- Ability to develop solutions to a diverse range of problems using structured problem solving tools and sound analytical and conceptual thinking.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, our work in Quality is important and valued. We have an unrivalled forward-looking mindset, making it the perfect place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. We are proactive, science-based, and solutions-oriented. Our ambition keeps pushing us forward, but it's our pragmatic focus that keeps us delivering what will have the biggest impact on our patients. We are a team of ambitious people who want to go far and achieve. We take Quality seriously and strive to shift the mindset around Quality. It's more than just following procedures and regulations; it's about adding value for our patients, which ultimately benefits the business.

Ready to make a difference? Apply today

Date Posted

24-Jun-2024

Closing Date

07-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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