Medical Device Quality Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Irving, TX 75061
Description:
Responsibilities:
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Design/Change Control - Software responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
- Risk Management - Understands and applies basic Risk Management principles. Participate in the development and/or modification of Risk Management Files, FMEA's, etc.
- Design Verification/Validation - Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.
- Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
- Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
- Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance with site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
- Quality Engineering - Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective pro.
- The position will be providing software quality support for new medical device product development which includes activities and tasks related to the software development lifecycle (SDLC) and FDA design controls (ISO 13485).
- BS degree in engineering, technical field or equivalent. Preferably software related such as computer science.
- Minimum 5 years medical device software development lifecycle (SDLC), FDA design controls, software quality engineering, software verification/validation including traceability to requirements and risk analysis, defect reporting, and software configuration management.
- In Vitro Diagnostics (IVD) preferred.
- ISO 13485 (Medical Device QMS) and ISO 14971 (Medical Device Risk Management).
- FDA design controls (820.30).
- Software verification/validation experience.
- onsite preferred, may do phone screening interview before any onsite interviews.