QA Manager Combination Product and Device 80-100% (m/f/d)

We're proud to be a first-tier supplier to Roche, and for our valued partner, F. Hoffmann-La Roche Ltd. in Basel, we're seeking a highly motivated Senior Quality Engineer specializing in Medical Devices and Combination Products. This is a temporary position for one year with the possibility of extension.

Key Tasks & Responsibilities

• Ensuring Compliance: Serving as a crucial quality support for allocated Device Development or commercial projects, ensuring all projects adhere to applicable design control and risk management procedures.
• Facilitating Integration: Collaborating with all QA representatives from other functions to ensure the quality robustness of the interface between the Drug Product and the Device Component forming the Combination Product.
• Driving Proactive Quality: Creating and deploying Risk Management Plans/Reports, actively participating in and facilitating FMEAs, defining Delivery System specifications accordingly (including Drug Product / Component interface), and ensuring all necessary release GMP documentation is completed and in place.
• Solving Complex Challenges: Ensuring and driving quality resolution for investigations related to the delivery system, and assessing change controls. You'll represent the department at Quality Review Board and Change Review Board meetings.

Key Must-Haves

• Education: Bachelor's degree in Life Sciences, Chemical, or Mechanical Engineering (Master's preferred).
• Experience: At least 2 years of hands-on experience and expertise in device quality or device development within a GMP-regulated environment.
• Expertise: Demonstrated capability of applying risk management concepts and tools, and deploying Design Control.
• Industry Knowledge: Understanding of the biotechnology industry and specifically combination products, with experience working in a global environment preferred.
• Regulatory Savvy: Sound knowledge of cGMPs and essential international regulatory requirements (e.g., QSR, MDR, ISO 13485).
• Collaboration & Communication: Well-developed teamwork and collaboration skills, with the ability to communicate clearly and professionally both verbally and in writing.
• Problem-Solving: Demonstrated problem-solving and decision-making skills; hands-on working experience with tools like Six Sigma / DMAIC is preferred.
• Motivation: Highly motivated and willing to perform tasks with varying complexity.
• Language: Fluent in English is a must; German is a definite plus!

Benefits

• Enjoy exclusive discounts all year round at renowned retailers and over 200 top brands.
• Benefit from fleet discounts when purchasing a new car or receive consistent fuel discounts with our fuel card.
• Be part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare.
• Work on a state-of-the-art campus with green spaces, social areas, and an inspiring atmosphere.
• Take advantage of attractive fitness and swimming pool offers or use the gaming room as a creative retreat.

Ready to elevate quality and innovate for health? Don't hesitate and submit your complete application documents online today. We look forward to hearing from you!
 

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Kontakt
Kristof Wildmann

Arbeitsort
Kaiseraugst

Pensum
80 - 100%

Position
Mitarbeiter

Branche
Elektro + Mechanik