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Senior QARA Specialist
Senior QARA SpecialistWerfen Immunoassay • Catalonia, Spain
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Senior QARA Specialist

Senior QARA Specialist

Werfen Immunoassay • Catalonia, Spain
Hace más de 30 días
Descripción del trabajo

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 software life cycle process (IEC 62304).

Desirable:

  • 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
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Senior QARA Specialist • Catalonia, Spain

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