We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Design Quality Assurance and help shape policies that change lives.
Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.
A Day in the Life
As a Design Quality Engineer, you will be ensuring that the design control requirements are fulfilled as part of PDP and CDP projects team
You will manage the risk management activities and documentation from the early stages of the development process and throughout the product lifecycle.
You will review and approve product Verification and Validation documentation
You will manage the Risk management file throughout the product life cycle
You will review and approve design documents and processes in accordance with Design Controls standards and company’s policies.
You will track product Standards to guide others on their correct implementation.
You will Implement statistical tools usage in R&D, e.g. Cpk, MSA, DOE.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile.
The employee is also required to interact with a computer, and communicate with peers and co-workers.
BSc Engineering degree or higher.
At least 2 years prior experience related to design quality in a medical device company.
Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971, IEC62304 and the Medical Device Directive.
Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis.
Reliability analysis and test methods.
Familiar with software and electrical medical devices related standards.
Demonstrated scientific analysis abilities.
Nice to Haves.
6 sigma Certificate is an advantage.
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