Quality Assurance Specialist

4 months ago

Stockholm, Sweden Permobil Full time

QUALITY ASSURANCE SPECIALIST

Wouldyou like to work in an international environment where you will make adifference every day? We are looking for game-changers to join us as weinnovate for individuals and develop the world’s most advanced assistivesolutions.

At  Permobil ,the people who use our products come first. Our purpose is to create advancedassistive solutions that make the lives of adults and children living withdisabilities more enriching. Our people are passionate about pushing theboundaries of technology to deliver innovations that improve lives. We are asustainable and responsible business committed to continuous improvement, andour customers can trust us to provide market-leading solutions driven byinsights-based clinical data.

Positionoverview

Weare now looking for the Quality Assurance Specialist to join our team The primaryobjective is to help design and maintain quality processes to assure thatprocess and product compliance is maintained through proper processes withinthe QMS, following Medical Device Regulation (MDR), Quality System Regulation(QSR) as well as other applicable regulations.

KeyResponsibilities:

Develop, manage, and review Quality Management System (QMS) processes, Ensure QMS compliance with medical device regulations (MDR, ISO13485, FDA), Support the management of CAPA, non-conformance, change management, and audits, Review QMS efficiency, focusing on key processes and reporting, Conduct QA reviews, investigate non-conformance, and manage CAPA, Serve as an internal auditor and coordinate external audits, Analyze quality data and identify training needs, Address Quality Assurance and Regulatory Compliance issues, Initiate and/or lead projects to improve quality assurance processes, Coordinate and support on-site audits conducted by external providers.

Qualifications& Skills:

Master’s or bachelor’s degree preferably in science or engineering, 5 years of working experience, Good knowledge of quality systems and quality assurance within regulated industry (preferably life-science), Preferred previous experience from Med Tech or Pharma industry (knowledge of applicable regulatory requirements and ISO), Capability in being a manager, leading operations with or without personnel responsibility, Fluent in oral and written English, Strong computer skills including Microsoft Office.

Whyis Permobil the next step for you?

You’ll make a difference. Every day.
Everything we do leads to understanding and improving the lives of our users. Through our evidence-based innovation, we make a difference to people’s lives. You’ll make your mark as part of our future.
We collaborate with colleagues across borders to Innovate for Individuals. The impact you make personally could lead change around the world. You’ll feel welcome from day one.
We’re known for being great colleagues, who are collaborative, fun and at the cutting-edge. Everyone at Permobil cares as much as you do about making a positive difference.

ApplicationProcess

Wewill conduct selection continuously so send us your application today or before  October10th at the latest

Permobilis an equal opportunity employer committed to diversity and inclusion. Wewelcome applications from all qualified individuals.

Foradditional information about the position, please contact Zara Marzouki, QualityManager QMS,

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