Job Description

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

Commercial Quality Partner (EMEA & LATAM)

As we continue to grow as one QuidelOrtho we are seeking a Commercial Quality Partner (EMEA & LATAM). The Quality Partner (EMEA & LATAM) represents the Global Quality and Compliance organization within the EMEA & LATAM Commercial leadership team. This role can be based in either the UK, Germany or Spain.

Your new role:

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. This ensures QuidelOrtho's Right to Operate and enables the business to adapt with speed and confidence in a rapidly evolving environment within the EMEA & LATAM region.

This role operates across all Quality disciplines including but not limited to Quality Operations, Product Care & Technical Quality, Product Health & Monitoring and Quality Systems Excellence. Through engagement with the Quality Lifecycle teams will strengthen scientific and operational rigor, ensure sustainable compliance with applicable local regulations, leading and participating in initiatives to drive harmonization of processes and practices across the Global Quality Organization.

The Commercial Quality Partner with collaborate with Regional Commercial Leadership, Business Unit Product Management, Regional Supply Chain and Regulatory Affairs to advance Quality excellence, accelerate innovation, and to build and maintain confidence in product and process quality.

What you’ll be doing:

• 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). Advises and enables Commercial Teams in the
  management of quality issues with customers and third-party partnership.
• Provides Quality support for the sales process, including coordination of Tender Support, completion of customer questionnaires and as necessary customer visits.
• Ensure Quality systems, products, processes, and tools comply with global and regional regulatory requirements, including but not limited to ISO 13485, FDA 21 CFR 820, IVDR, ANVISA RDC 830/202.
• Partners with other functional Quality teams, to deploy global procedures, tools, metrics and process excellence initiatives, ensuring standardization of Quality processes and documentation across the region to improve compliance, efficiency, and
  integration across the region.
• Supports inspection readiness and regulatory engagement, contributing technical expertise and ensuring sustainable compliance. Identifies and assesses quality risks within the region and works to implement mitigation strategies in collaboration with the Global Quality Team.
• Provides guidance, coaching and mentorship to more junior Quality professionals, fostering scientific integrity, quality and compliance management, and a continuous improvement mindset.

The Individual

Required:

• 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

Preferred:

• Advanced degree (MS, PhD, or equivalent) in a scientific or engineering discipline.
• Experience with digital Quality systems, data analytics, or automation tools.
• Lean, Six Sigma or equivalent continuous improvement certification.
• Spanish language skills

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com

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