Quality Management Specialist

3 semanas atrás

São Paulo, São Paulo, Brasil Danaher - Global Tempo inteiro
Quality Management Specialist - LATAM

Cepheid, a Danaher operating company, is seeking a Quality Management Specialist to join our team in LATAM. As a key member of our Quality Team, you will be responsible for deploying and implementing strategic and tactical plans to ensure compliance with applicable Quality System and country-specific regulatory compliance requirements in relation to business objectives and initiatives within LATAM countries.

This role is part of the Quality Team and will be located On Site, at Brazil's office located in São Paulo. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

Key Responsibilities:

  • Establish and maintain Quality Management Systems (QMS) in accordance with CEP and relevant regulatory requirements (including ISO 13485, ISO 14971, ISO 9001, In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), FDA (Quality System Regulation) 21 CFR Part 820, 21 CFR Part 11, and Medical Device Single Audit Program (MDSAP) as applicable.
  • Act as the site Quality Management Representative for the Cepheid sites within the region and ensure the achievement and maintenance of site certifications/registrations for the Cepheid sites within the region.
  • Define sites' annual quality plans and specific quality goals. Plan and conduct Quality System Management reviews for the Cepheid sites within the region.
  • Ensure that all aspects of Quality and Regulatory Compliance applying to CPs, 3PLs, and ASPs are satisfactory (e.g., traceability, storage conditions, in-country specific regulatory requirements) and documented (e.g., quality or distribution agreements).
  • Support Commercial and Customer Care teams in the execution of the Channel Partners (CPs) and Authorized Service Providers (ASPs) Third Party Logistics (3PLs) selection and performance monitoring processes, including compliance audits and visits as needed.
  • Provide quality and regulatory compliance support to market expansion projects. Ensure the quality and regulatory compliance activities are covered and deliverables are supplied to the project (quality agreements defined, validation performed, etc.).
  • Identify the local and country-specific regulatory requirements. Communicate and promote the importance and value of Quality to all stakeholders, including senior management, associates, customers, suppliers, and regulators.

Requirements:

  • Bachelor's or Master's degree with previous experience in maintaining and continuously improving Quality Management Systems compliant with ISO 13485, ISO 14971, FDA QSR 21 CFR 820, In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
  • Experience with operating in an international multi-site company and matrix organization structure, leading changing conditions, processes, and approaches.
  • Fluent in Portuguese and English; Spanish is desired.

Travel & Motor Vehicle Record Requirements:

  • May require national and international travel.
  • Valid driver's license.

Cepheid offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve.

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