Quality Engineer 1, Design Assurance

Position Summary

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.
4.    Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.
5.    Apply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize cost of quality throughout the product’s lifecycle.
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 R&D, Marketing and Operations to make risk-based decisions associated with nonconformances and technical complaints.
9.    Understand applicable external regulations and internal standards that drive compliance and apply them in their daily function. Perform audits of Design History Files and support both internal and external audits.
10.    Partner with Usability Engineering SMEs and R&D to assess the Usability engineering requirements of product and packaging throughout design and development.
11.    Participate in the review and approvals of biocompatibility and clinical evaluation plan/report.
12.    Perform gap assessments on relevant standards / regulations when necessary.
13.    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.
14.    Review and approve material assessment documentation.
15.    Develop and validate test methods. Identify and apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies such as Gage R&R.
16.    Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.

Education / Experience Requirements

Qualification    :    
•    B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered). 

Experience    :    
•    Recommended 3 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry).  

Specialized skills / technical knowledge:
•    ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB). 
•    Ability to train, mentor, and coach others.
•    Thorough 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, adaptability to change, and achievement.

Specialized Skills / Other Requirements