Quality Engineer Ii, Design Assurance

hace 1 semana

Tecate, Baja California, México Teleflex A tiempo completo

**About Teleflex Incorporated**

**Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end.
We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers.
Our employees are dedicated to the Global Operations Enterprise Excellence journey.
Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
**Position Summary**:
As a member of a cross-functional team, the Quality Engineer, Design Assurance is responsible for quality throughout new product development and improvement up to and including technology transfer and commercialization.
The Quality Engineer, Design Assurance ensures that applicable elements of the Quality System and external standards are followed.
As the voice of Quality, the Quality Engineer, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization.
**Principal Responsibilities**:
1.
Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
2.
Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.
3.
Analyze post-market surveillance data periodically throughout a product's lifecycle to feed back into it's risk file in order to reflect it's current risk profile.
Support Clinical and Medical Writers in the analysis of available clinical data, as required.
6.
Ensure compliance of all practices to the Quality Management System.
Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
7.
Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
8.
Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and technical complaints.
10.
Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development.
12.
Perform root cause analysis of identified issues and identify appropriate corrective and preventive action.
Use the NC and CAPA systems as needed to structure activities.
13.
Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
**Education / Experience Requirements**:

- B.A.
or B.S.
degree in a technical discipline, such as engineering or science (equivalent experience may be considered).
- 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).
**Specialized Skills / Other Requirements**:

- ASQ certification preferred (e.g.
CQE, CQA, CMDA, CRE, CSSGB/CSSBB).
- Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
- Proficient in MS Office, and Minitab or other statistical softwares.
- Strong organizational and time management skills to meet deadlines while managing multiple projects.
- Strong analytical and critical thinking skills.
- Proficient in technical report writing and review.
- Strong verbal and written communication skills.
- Foster a positive culture of growth, collaboration, and achievement across the organization.

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