Position

Quality Assurance Specialist

Quality Assurance

Position Summary and general duties

Under the supervision of the Quality Director, the main tasks will be:

·       Initiating improvements to the QMS, ensuring compliance to all relevant quality standards and regulatory requirements, including ISO 9001, ISO 14001, ISO 13485, GDP and the applicable regulations.

·       Investigating deviations and non-conformities in cross-functional teams,

·     Handling: corrective and preventive actions, change control process, supplier and subcontractor qualification process, document control process, SOPs & quality training,

·       Managing and coordinating software validation in the scope of QMS,

·       Quality documentation writing including the SOPs, quality reports.

·       Participating actively in the monitoring, analysis of the quality processes and in Quality Management review.

·       Establishing and updating the Technical File, and Medical Device File,

·       Participating actively in the risk management process and in the promotional documents/materials review and approval process,

·       Supporting internal Global RA, Operational departments and providing collaborative support for commercial teams,

·       Participating in Regulatory Body audits such as FDA, Notified Body,

·       Above mentioned tasks are not exhaustive and can be updated according to company’s needs. 

 

Desired Skills 

·       Bachelor’s in science/Engineering discipline or equivalent with minimum 1 years’ experience as Quality Assurance in health industry

·       Adhere to DKT WomanCare Core business and Company values and Behaviors, such as defend women’s rights to access sexual and reproductive health, regardless their origin, religion, social status, income level or age and defend freedom through responsibility and accountability. This includes access to rights to family planning, contraception and abortion.

·       High achieving and energetic person, project and success oriented.

·       Very good organizational abilities, flexibility to understand realities in an international context.

·       Excellent verbal and written communication skills.

·       Fluent in both written and spoken English, French. English oral and writing skills are mandatory.

·       Problem solver, individually and in working teams. 

·       Capability to work independently at the office but also in teleworking mode. 

·       Proactive and detail oriented. 

·       Strong command of Microsoft programs (Word, Excel, and PowerPoint).

·     Business trip: needed but not frequent (<2 weeks per year)

 

 

 


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