Design Quality Engineer- Maternity leave replacement

Description

About this opportunity
The Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and new products

Key Responsibilities

In this role, you will…
AS a Design Quality Engineer (DQE) you will plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of medical equipment including cooperated with the design and development team, and apply quality management principles throughout the product life cycle.
DQE's main responsibilities include:
• Review design documents and specifications, to ensure that they meet relevant standards and regulations
• Participant in risk assessment, identify and reduce potential risk quality
• Take part in the design and verification process

Skills, Knowledge & Expertise

In this role, you’ll need …
Bachelor's degree in engineering or equivalent
At least 4 years of experience in Design quality
Experience from medical device industry - Big advantage
Excellent written and spoken English
Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
Good ability to comprehend multi-disciplinary systems and processes
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
Ability to work independently with minimal supervision
Computer skills (Microsoft Word, Excel, PowerPoint)
Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc. preferred

About Align Technology
Your growth and well-being:

At Align, every smile matters. We are committed to supporting your health, contentment, and professional development through tools and initiatives designed to help you thrive. While benefits may vary by location, you can expect the following wherever you join us:
Health and well-being programs to keep you thriving in both body and mind.
Employee discounts on Invisalign products.
Learning opportunities though online learning resources and support for your individual development plans.
Inclusive workspace that fosters diversity and collaboration.
Country-specific details will be shared with you by your recruiter during the interview process.

Discover Align:

At Align Technology, 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.

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.

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 diversity and nurture employee well-being?
Explore Align's culture here!
Want to discover more about exocad and Cubicure? Click on their names for additional information.

Applicant Privacy Policies:

Review our Applicant Privacy Policies for additional information.

Global Diversity Statement:

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.

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.