PWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Immunoassay business line, we research, develop, and manufacture customized assays and biomaterials. /ppbr/ppWe operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. /ppbr/ppWithin a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products. /ppbr/ppstrongKey Accountabilities /strong /ppBe a key part of a team where you will: /pulliCollaborate in maintaining the quality system documentation processes and procedures adopted by the company. /liliInvestigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence. /liliCoordinate and support the preparation of software technical documents appropriate for regulatory submissions. /liliSupport the regulatory submissions for market authorization for medical device products. /liliConduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures. /liliFacilitate the approval process for software releases. /liliDisseminating knowledge about the Quality System and regulatory requirements. /liliReview Promotional and advertising materials. /liliOversee post-market surveillance activities related to medical device products. /liliOffer guidance and mentorship to QARA team members at lower levels /li /ulpbr/ppstrongNetworking/Key relationships /strong /ppThe main relationships within to the Werfen Group are: /pulliQARA Manger, QA Leads, Validation Led /liliFactory Lead and Solution Leaders /liliCustomer /liliApplication Lifecycle manager (ALM) /liliNotified Bodies and Competent Authorities for product regulatory compliance. /liliThis position may also require also cooperating with other companies inside Werfen. /li /ulpbr/ppstrongMinimum Knowledge Experience required for the position: /strong /ppbr/pulliEngineer, computer Science or other Technical carrier, or equivalent work experience. /liliA minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sector /liliAdditional Skills/Knowledge: /liliKnowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971,..). /liliKnowledge and experience working in Medical device software life cycle process (IEC 62304) /liliDesirable: /liliKnowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA..) /liliInternal auditor qualification for management systems or knowledge of auditing techniques /li /ulpbr/ppstrongSkills Capabilities: /strong /ppThe ideal candidate for this position will exhibit the following skills and competencies: /pulliGood level of Technical and Conversional English. /liliTeam player with ability to work independently. /liliExcellent and effective written and verbal communication skills. /liliExcellent interpersonal skills, good judgment and analytical skills. /liliEffective time management and organizational skills /li /ulpbr/ppstrongWhat we offer: /strong /pulliA meaningful project that will impact the quality of laboratory software medicine worldwide /lili3 days a week working from home /liliMulticultural and friendly team /liliExciting opportunities for professional development. /liliOngoing training /liliSocial benefits: Canteen, nursery check, English training... /liliAll the benefits according to the chemical agreement /li /ulpbr/ppOur Purpose:em We contribute to the advancement of patient care around the world through innovative specialized diagnostics /em /ppbr/ppJOIN US! /p