Quality Partner – Commercial, EMEA, LATAM
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Job Description
Quality Partner responsible for technical quality and compliance in EMEA & LATAM for diagnostics company. Collaborating cross-functionally to enhance quality systems and ensure regulatory compliance.
Responsibilities:
- The Commercial Quality Partner (EMEA & LATAM) provides technical quality and compliance expertise within the region to address quality issues maintain compliance and drive continuous improvement in quality systems and processes.
- Serves as the regional subject matter expert, within Global Quality & Compliance, providing technical and quality leadership, representing the Quality Function within the Commercial Leadership Team.
- Serves as a first point of contact for Quality issues identified within the Regional Commercial Team.
- Collaborates cross-functionally to ensure Quality requirements are integrated throughout the product lifecycle, from design to commercialization and post-market to address issues impacting the Regional Commercial Team.
- Uses data and analytics to monitor Quality system performance, identify risks and opportunities for the Regional Commercial Team.
- Recommends improvements based on trend analysis / voice of the customer.
- Engages with the Quality Life Cycle teams, championing the voice of the customer, ensuring that Quality processes and decisions support patient safety, regulatory compliance, and business continuity influencing prioritization across the business to address quality & compliance issues to drive business and customer value.
- Educates and provides guidance to Commercial Teams on Quality System requirements and regulations as needed (pertinent to their roles).
Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related technical discipline required.
- Demonstrable progressive experience in Quality or Compliance functions within the Medical Device, IVD, or Biopharmaceutical industries.
- In-depth understanding of global Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, ANVISA RDC 830/2023 and IVDR.
- Strong technical and analytical skills, with the ability to interpret complex data and drive fact-based decisions.
- Demonstrated ability to influence and collaborate effectively in a matrixed, cross-functional, and global environment.
- Experience in QMS development, process improvement, and risk management.
- Excellent written and verbal communication skills with experience presenting to technical and executive audiences.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
- Fluent English language skills.
Benefits:
- Health insurance
- Professional development opportunities
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