SQAFYI - Software QA Resource - FYI

US: Design Quality Engineer - QA

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 25-Jul-2018

Design Quality Engineer - QA

ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:

Serves as the Quality & Regulatory stakeholder for product development release team Ensures quality products are developed in accordance to governing regulations and processes Prepares all QARA product development deliverables Serves as key member of product risk assessment teams Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development Participates and supports various development activities including design reviews and Product Safety Committee Reviews and approves product design documentation Actively participates and/or leads Design History File audits and follow-on remediation efforts as required Support root cause analysis activities for the investigation of product complaints Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEA’s, etc. Assists in the planning and execution of verification and validation testing to ensure adequate test coverage for new products and sustaining design changes. Assists in planning and execution of engineering change orders for hardware and software-related product changes Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes Responsible for managing all tool and process validations – reviews and approves all validation documentation Maintains Master Validation List (MVL) and facilitates annual review of MVL Reviews quality data to identify high priority issues relating to safety, complaints and systemic customer satisfaction Responsible for product change assessments, health hazard evaluations and product recall documentation Assists with CAPA investigations and ensures corrections and/or corrective actions for identified nonconformances are implemented Participates in site visits with customers and customer feedback workshops Identifies and implements process improvement initiatives, especially scalable, risk-based processes Works with other Hill-Rom entities to establish Communities of Practice in Risk Management, Software Quality Assurance, Software Development, and other strategic areas as required.

B.S. in Engineering (Electrical, Biomedical, etc.) or other technical degree 3+ years’ experience in quality engineering / quality assurance role under the Quality System Regulation, medical device or other FDA regulated industry required Experience in New Product Development/ Medical Device Design Controls required Experience with software-based products required Extensive experience with quality tools and methods required (e.g. DFSS, root cause analysis, Software FMEAs, etc.) Knowledge of Medical Device Directive, and/or ISO Quality System Standards desired Experience with requirements management tools and systems engineering concepts desired CQA, CQE, CSQE, or RAC certification desired Excellent analytical decision making and problem solving skills Ability to partner with individuals to build relationships throughout the Hill-Rom Corporate organization Demonstrated ability to work and perform in team environments

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Thank you,
Team SQAFYI - Software QA Resource FYI

US: Design Quality Engineer - QA