Transforming smiles,
changing lives.
Senior Manager, Validation & Verification
We are looking for a Validation & Verification Senior Manager to join our team. As part of the role, you will work closely with R&D to specify, execute, and report the required tests, as well as with QA / RA to ensure that the medical QMS complies. In this role, you will play a key role in ensuring the quality and reliability of our products through rigorous testing and validation. A strong technical background, excellent problem-solving skills, and the ability to work collaboratively with various teams are required for this role.
In this role, you will…
- Develop planning control of verification and validation activities, ensuring compliance with regulatory standards and company quality objectives
- Hire and direct staff to meet scheduled commitments.
- Evaluating and understanding our current state of testing and driving change to increase test automation and improve our overall testing practices.
- Developing test strategies for test automation and manual verification and validation.
- Develop the test development processes including designs, reviews, implementations, and test execution.
- Continuously improving testing methodology, best practices, and standards to provide consistent testing across products.
- Work closely with other teams to build and maintain testing infrastructure and tooling.
- Work collaboratively with others to drive best practices and reduce the cost of V&V effort.
- Periodically review how the test strategy aligns with the latest available technologies and industry trends
In this role, you’ll need…
- BSc degree in System, Mechanical, Electrical or Biomedical Engineering or related field
- Proven experience in leading and conducting V&V activities of Medical devices, including writing, and executing test plans and protocols for medical devices with a strong emphasis on QA/RA and problem-solving
- Experience with multi-disciplinary medical device companies.
- Strong technical background, and understanding of complex systems including processes.
- Formal and practical knowledge of testing methodologies including design and implementation of test protocols, test harnesses tools, infrastructures, and test automation.
- Implementation of quality methodologies (Six Sigma and, DFx)
- Excellent written and verbal communication skills - Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies
- Deep understanding of Automation software tools and testing, technology strategy, healthcare processes, and regulatory requirements, including FDA 510(k), EU MDR, hardware compliance, EMI/EMC, QMS, and validation protocols.
- Fluency in English – written and spoken.
À propos de Align Technology
Your growth and well-being:
At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:
At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee-exclusive discounts on Invisalign products.
- Learning opportunities through online learning resources and support for your individual development plans.
- Inclusive, global workplace that fosters collaboration, recognition and belonging.
Country and/or role specific details will be shared with you by your recruiter during the interview process.
Discover Align:
We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.
Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.
We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.
At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.
As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.
Eager to learn how we embrace our global differences and nurture employee well-being?
Explore Align's culture here!
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Equal Opportunity Statement:
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
Review our Applicant Privacy Policy for additional information.
Equal Opportunity Statement:
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
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