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- Tasks: Lead quality initiatives and ensure compliance in a dynamic healthcare environment.
- Company: Join QuidelOrtho, a global leader in diagnostics with a people-first culture.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Collaborative environment with mentorship opportunities and a commitment to continuous improvement.
- Why this job: Make a real impact on healthcare quality and patient safety across EMEA & LATAM.
- Qualifications: Degree in Life Sciences or Engineering; experience in Quality or Compliance required.
The predicted salary is between 60000 - 80000 £ per year.
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.
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, we 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 will 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 partnerships.
- 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.
Quality Partner, Commercial (EMEA & LATAM) employer: QuidelOrtho
Contact Detail:
QuidelOrtho Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Partner, Commercial (EMEA & LATAM)
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and values, especially how they relate to quality and compliance. This will help you stand out as someone who truly gets what they're about.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers, especially when discussing your experience in quality management.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about joining our team.
We think you need these skills to ace Quality Partner, Commercial (EMEA & LATAM)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Partner role. Highlight your experience in quality and compliance, especially in the medical device or IVD sectors. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality in diagnostics and how you can contribute to our mission. Keep it engaging and relevant to the role.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use data and examples to demonstrate how you've improved quality systems or processes in your previous roles. We love seeing results!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss any important updates from us!
How to prepare for a job interview at QuidelOrtho
✨Know Your Quality Standards
Make sure you brush up on the key quality standards relevant to the role, like ISO 13485 and FDA regulations. Being able to discuss these in detail will show that you’re not just familiar with them but can also apply them in real-world scenarios.
✨Showcase Your Analytical Skills
Prepare to discuss how you've used data and analytics in past roles to monitor quality systems or identify risks. Bring specific examples that highlight your ability to drive fact-based decisions, as this is crucial for the Commercial Quality Partner position.
✨Demonstrate Cross-Functional Collaboration
Think of instances where you’ve successfully collaborated with different teams, especially in a matrixed environment. Be ready to explain how you influenced others and integrated quality requirements throughout the product lifecycle.
✨Prepare Questions About Continuous Improvement
Have some thoughtful questions ready about how the company approaches continuous improvement and quality excellence. This shows your commitment to fostering a culture of quality and your eagerness to contribute to their mission.