Quality Specialist (Laboratory Diagnostics)

Abbott

Abbott

Quality Assurance
Bucharest, Romania
Posted on Sunday, September 15, 2024

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Competitive salaries, bonus potential and excellent package of benefits.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

For our Core Diagnostics Division CDx we are looking for a highly motivated, self-driven professional to join our regional, EEMEAP quality team as a Quality Specialist. This position will work out from our office in Bucharest, Romania.

Primary objective and impact of the role:

  • Supports Quality System compliance in a specific region or regions.
  • Supports a specific process or processes for the whole Europe/EEMEAP as Subject Matter Expert (SME), its backup, or part of the team.
  • Operates under Quality and Regulatory directives and Abbott policies and procedures.
  • Follows local regulations and international industry/ Quality System standards.

What You'll do:

  • Supports the Manager QA Region to ensure Europe/ EEMEAP and Region Quality System effectiveness and compliance.
  • Performs internal, storage facilities and supplier audits.
  • Supports / prepares/ coordinates external audits.
  • Review & approve locally developed AdPromo material in local language on behalf of Regulatory Affairs.
  • Supports the EEMEAP common Quality System and QS processes: e.g. Field communications, supplier evaluation, audits and CAPA, warehousing, AdPromo, document control and record keeping.
  • Review Abbott policies & procedures, and update Quality documentation accordingly.
  • Manage any audit input by initiating changes to affected processes following MIMS change control procedures.

Required qualifications and background:

  • University degree in life science or related scientific background (i.e. Lab Technician, Biology, Chemistry, Pharma, M.D., Engineer) preferred.
  • At least 3 years of experience in QA, RA roles (preferably in diagnostics, medical devices or pharmacy), preferably in an international environment.
  • Quality Assurance in a commercial affiliate at the diagnostic/ medical device/ pharmaceutical industry is preferred.
  • Native or bilingual level of Romanian language is a must.
  • Excellent command of written and spoken English is a must.
  • Strong attention to details and high working culture.
  • Strong teamwork skills, including working with international teams.
  • Readiness to travel (approx. 5-10% of time).
  • Readiness to work in an office-based model.
  • Experience to work in international environment/ projects is preferred.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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