Qa Manager, Randstad

Randstad

Location:
Switzerland, Basel

Category:
-

Contract Type:
Employment contract

Salary:

Not provided

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Job Description:

The Quality Project Manager position will provide in-depth Device Quality expertise for drug delivery systems (under development or commercial) to ensure compliance with applicable standards and regulations. The position will be a support of the Quality SPOC (single point of contact) for the Device Development and Device Industrialization project team.

Job Responsibility:

Serve as the Quality SPOC for allocated Device Development or commercial projects and ensure all projects follow the applicable design control and risk management procedures
Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product
Create and deploy Risk Management Plan / Report
Actively participate up to facilitating FMEAs
Define Delivery System specifications accordingly including Drug Product / Component interface, and ensure all necessary release GMP documentation are completed and in place
Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls
Represent the department at Quality Review Board and Change Review Board meetings

Requirements:

BS degree in Life Sciences discipline or Chemical/mechanical engineering
Min. 2 years experience and hands on expertise in device quality or device development
Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred
Knowledge of cGMPs and relevant international regulatory requirements (QSR
MDR
ISO13485, etc.)
Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
Very motivated and willing to perform tasks with varying complexity
Fluent in English

Nice to have:

Graduate degree preferred
German language skills

What we offer:

Remote/home office allowed max 2 days per week
Standard working hours

Additional Information:

Job Posted:
June 02, 2025

Expiration:
July 31, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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Qa Manager