Senior QARA Specialist
4 days ago
Lliçà d'Amunt
JOB SUMMARY Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products. KEY ACCOUNTABILITIES • 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., • 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 levels NETWORKING / KEY RELATIONSHIPS The main relationships within to the Werfen Group are: • QARA Manger, QA Leads, Validation Led, • Factory Lead and Solution Leaders, • Customer, • Application Lifecycle manager (ALM), • Notified Bodies and Competent Authorities for product regulatory compliance., • This position may also require cooperating with other companies inside Werfen. MINIMUM KNOWLEDGE & EXPERIENCE REQUIRED FOR THE POSITION • Education: 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 sector., • Additional Skills/Knowledge:, • Knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971,..)., • Knowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA..), • Internal auditor qualification for management systems or knowledge of auditing techniques. SKILLS & 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 skills. TRAVEL REQUIREMENTS: • Up to 5% of time