Senior QARA Specialist
hace 7 días
OverviewWithin a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products.ResponsibilitiesKey AccountabilitiesCollaborate in maintaining the quality system documentation processes and procedures adopted by the company.Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence.Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.Support the regulatory submissions for market authorization for medical device products.Conduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures.Facilitate the approval process for software releases.Disseminating knowledge about the Quality System and regulatory requirements.Review Promotional and advertising materials.Oversee post‑market surveillance activities related to medical device products.Offer guidance and mentorship to QARA team members at lower levelsNetworking/Key relationshipsThe main relationships within to the Werfen Group are:QARA Manger, QA Leads, Validation LedFactory Lead and Solution LeadersCustomerApplication Lifecycle manager (ALM)Notified Bodies and Competent Authorities for product regulatory compliance.This position may also require also cooperating with other companies inside Werfen.QualificationsMinimum Knowledge & Experience required for the positionEducation: Engineer, computer Science or other Technical carrier, or equivalent work experience.Experience:A minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sectorAdditional Skills/Knowledge:Knowledge and experience working with medical device international regulations and related standards (ISO , ISO ,..).Knowledge and experience working in Medical device software life cycle process (IEC )Desirable:Knowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA..)Internal auditor qualification for management systems or knowledge of auditing techniquesSkills & Capabilities:The ideal candidate for this position will exhibit the following skills and competencies:Good level of Technical and Conversional English.Team player with ability to work independently.Excellent and effective written and verbal communication skills.Excellent interpersonal skills, good judgment and analytical skills.Effective time management and organizational skillsIf you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer #J-18808-Ljbffr
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Senior QARA Specialist
hace 3 días
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen 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 Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Senior QARA Specialist
hace 7 días
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen 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 Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Senior QARA Specialist
hace 1 semana
Lliça d'Amunt, España Werfen A tiempo completoOverview Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products. Responsibilities Key Accountabilities Collaborate in maintaining the quality system documentation processes and procedures adopted by the company. Investigate and resolve quality issues, implementing corrective and...
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Senior Medical Device Software QARA Lead
hace 7 días
Lliçà d'Amunt, España Werfen A tiempo completoA leading medical device company in Spain is seeking a Quality Assurance Regulatory Affairs (QARA) professional. The ideal candidate will have over 5 years of experience in Quality Assurance and knowledge of medical device international regulations. Responsibilities include maintaining quality documentation, preparing technical documents for regulatory...
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Senior QARA Specialist
hace 16 horas
Lliça d'Amunt, España Werfenlife SA. A tiempo completoWerfen 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 Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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lliçà d'amunt, España Werfenlife SA. A tiempo completoWerfen 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 Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Lliça d'Amunt, España Werfen A tiempo completoWithin a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products. Collaborate in maintaining the quality system documentation processes and procedures adopted by the company. Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence....
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Senior Field Specialist
hace 16 horas
Lliça d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Within a...
