Description
The Associate Quality Engineer develops, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance. In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification.This role is responsible for independently identifying, proposing solutions and implementing improvements to the quality and effectiveness of products and processes.
The position will oversee that the quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820 and ISO13485 (and other regulations as applicable) and for providing data regarding the performance of the quality system that will be presented to management with executive responsibility for review.
This role utilizes extensive internal and external partnering skills and must be knowledgeable with other cross-functional disciplines and processes such as R&D, Regulatory, Clinical and Manufacturing.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Product Development Engineering Support:
- Responsible for all Quality Assurance functions pertaining to New Product Development.
- Participate as a core team member throughout the product development process and provide risk management support and follow-up.
- Assist in design transfer activities of new products.
- Develop and lead quality plan initiatives.
- Support and/or conduct verification and validation testing.
- Through risk management, use of statistical methods, design and process control activities, the QE will ensure that our products satisfy the needs of the customer.
- It is the responsibility of the QE to ensure that world class products continue to be developed and delivered through the application of sound quality principles and seeking continuous improvement of the design process.
- Participate on Design Assurance improvement programs to improve overall quality of new product designs and regulatory compliance.
- Monitor the design controls portion of the quality system for regulatory compliance.
- Ensures critical design characteristics are properly identified for correct levels of controls.
- Support teams that focus on Risk Analysis to include Risk Assessments, DFMEA's & PFMEA's.
- Help drive the Corrective Action process.
- Support various reviews throughout a project to include Phased Gate Design Reviews, Product Safety Committee, and Post Product Launch Analysis.
- Other tasks as assigned.
Education:
- Bachelor's degree in Science, Engineering or equivalent experience
Experience:
- Must be knowledgeable in Quality System Regulations, Medical Device Directive, ISO14971, ISO62304, IEC60601, and ISO13485 Quality Standards.
- Minimum of 1-3 years medical device and/or drug manufacturing/quality systems
- Strong background in statistical techniques, measurement tools and SPC tools
- QSR/ISO auditing experience
- ASQ or other quality related certifications (CQE, CQA, CRE, ISA Lead Assessor)
To find out more about Real please visit www.realstaffing.com