Commercial Quality Leadership Role in LATAM
2 semanas atrás
**Job Overview:**
Cepheid, a Danaher operating company, is seeking a talented individual to fill the role of Manager, Commercial Quality - 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.
**Key Responsibilities:
- Establish and maintain Quality Management Systems (QMS) in accordance with CEP and relevant regulatory requirements, including ISO 13485, ISO 14971, FDA QSR 21 CFR 820, In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), and Medical Device Single Audit Program (MDSAP).
- Act as the site Quality Management Representative for Cepheid sites within the region and ensure achievement and maintenance of site certifications/registrations.
- Define annual quality plans and specific quality goals for sites within the region.
- Plan and conduct Quality System Management reviews for Cepheid sites within the region.
**Requirements:
This position requires a 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, and In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). The ideal candidate should have experience working in an international multi-site company and matrix organization structure, leading changing conditions, processes, and approaches. Fluency in Portuguese and English is required, with Spanish being desired. Travel may be required, and a valid driver's license is necessary.
**Estimated Salary Range:** $80,000 - $110,000 per year, depending on location and experience.
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