Senior QARA Specialist

Barcelona - Spain

Monthly Salary: Not Disclosed

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

Werfen 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. We operate directly in 30 countries and in more than 100 territories through distributors.

Our Headquarters are in Barcelona Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded 2.2 billion in 2024 and our workforce is more than 7000 strong.

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/IVDRFDA..)
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

Werfen 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. We operate directly in 30 countries and in more than 100 territories ...