Dieses Projekt wurde vom Anbieter geschlossen. Es sind keine Bewerbungen mehr möglich.

Archiviertes Projekt - Quality Design Control Manager

Januar 2019

Juli 2019

CH-Basel-Landschaft

150 €

27.12.2018

RE-32883922_1545401420

Projektbeschreibung

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

Cooperation

* 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.

Kontaktdaten

Als registriertes Mitglied von freelance.de können Sie sich direkt auf dieses Projekt bewerben.

Login

direkt bewerben:


Noch kein Mitglied?

jetzt registrieren »

Projektstatistiken

Projektstatistiken sind für PREMIUM-Mitglieder einsehbar.

Sie suchen Freelancer?

Schreiben Sie Ihr Projekt kostenlos aus und erhalten noch heute passende Angebote.

jetzt Projekt erstellen »