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Archiviertes Projekt - Quality Design Control Manager

Januar 2019

Juli 2019


150 €




Quality Design Control Manager

(Medical Device/Combination Products)

For my client, an manufacture of biotechnology products for therapeutic areas in the region of Lausanne, I am looking for a Quality Manager Consultant.

* Duration: 6 months with possible extension
* Rate: please contact us directly for more information
* Location: Basel

Key Accountabilities:

Drug Delivery Development Projects

* Act as quality management representative in development projects for delivery systems for injectable drugs (drug injectors, reconstitution systems, connected devices):
* Ensure design control compliance
* Identify applicable quality and regulatory requirements
* Review and approve all project deliverables (internal and from suppliers)
* Review and approve training, promotional and labelling material
* Participate to design reviews
* Compile the Technical File, ensure CE mark approval
* Support regulatory submission worldwide
* Participate to the qualification and monitoring of suppliers
* Drug Delivery Maintenance
* Act as quality management representative for the maintenance of marketed medical devices.
* Perform the quality/regulatory assessment of proposed changes
* Supervise the change control process
* Ensure continued compliance to new or revised regulations and standards
* Maintain supplier qualification (periodic assessments, audits)
* Support regulatory submissions/renewals worldwide

Strategic Impact

* Ensure compliance of design control and maintenance processes to applicable regulations/standards and the company global policies and standards
* Ensure products are developed and maintained according to state of the art practices to reach ultimate product quality
* Lead the preparation of Technical File and regulatory submission files to ensure timely approval of devices worldwide, especially in the US
* Keep the Quality/Regulatory knowledge up to date

Scope of People Responsibility

* Be and essential members of multi-disciplinary teams
* Lead dedicated teams
* Act as independent quality and compliance representative for medical devices activities


* Global Business Franchise Medical Devices:
* Act as quality management representative in project teams
* Lead dedicated team efforts, e.g. regulatory submissions preparation, root cause analysis, new regulation/standard task force Cooperate with team members on a continuous basis through document review
* Global Quality: Be and active team member, promote quality initiatives
* Global Manufacturing & Supply:
* Collaborate actively on the development of combination products and on design transfers
* Regulatory Affairs: Ensure continued alignment with Regulatory Affairs teams (global and local) requirements and planning
* Legal: Ensure continued alignment with Legal teams (global and local) requirements, strategies and planning
* Procurement: Collaborate actively on selection of suppliers and establishment of contractual documents
* Suppliers: Ensure direct and continued contact with supplier teams through team meetings and document review

Your Profil/ Job requirements:

* Master, PhD or MD degree in science or related field

* Team player
* Global, international orientation
* Confident personality able to take independent decisions
* Supportive, keen to promote quality through example and continuous support
* Excellent knowledge of ISO13485, 21 CFR 820, ISO 14971
* Excellent knowledge of medical device regulations, CE marking, 510 (k), 21 CFR 4 for combination products
* Knowledge of electrical and software development standards (IEC 60601-1, IEC 62304) and of the radio-communication regulations (1999/9/EC, 47 CFR) is a plus
* Documentation writing skills
* Precise, rigorous, detail oriented

Languages: Fluent in English. Other European languages would be an asset.

Work Experience:

* At least 8 years of experience in quality and regulatory for medical devices
* Experience with EU, US and international regulatory submissions and strategies
* Experience with design control process for medical devices

If you are interested in this position, please send me your newest CV and contact me for more details.


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