| software Design QA With medical device data systems - Brooklyn Park, Minnesota-Hybrid at Brooklyn, New York, USA |
| Email: [email protected] |
| From: pankaj, Stellent IT [email protected] Reply to: [email protected] software Design QA With medical device data systems Brooklyn Park, Minnesota-Hybrid Phone+Skype 6+Month Job Description Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design. A Demonstrated team leadership skills and ability to prioritize, execute and report on projects A Knowledge on medical device data systems (MDDS) A Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA. A Knowledge on ISO and FDA/Quality System Requirements. (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CRF Part 820, 821, 822) A Experience working with HIPPA and GDPR. A Strong project and time management skills A Ability to work on multiple tasks concurrently with changing priorities A Proficient with of MS Word, Excel and PowerPoint A Experience with Class III active implantable products. Preferred Experience: A Experience in software design reliability, process and product quality assurance functions A ASQ certifications; CSQE, CRE, CQM, CQE, etc. A Experience working with bug tracking tools such as JIRA. A Experience with GHTF requirements for process validations, etc. Physical Requirements: A Ability to lift 30 lbs. POSITION CLASSIFICATION This position description is applicable to several classification levels which include the following titles: A Software Design Assurance Engineer A Sr. Software Design Assurance Engineer A Principal Software Design Assurance Engineer A Sr. Principal Software Design Assurance Engineer Classification levels are determined based on achieving department goals and objectives, years of experience, years of service with the company and manger input. Ensure quality system procedural requirements and development life cycle phases are followed. A Ensure proper cyber security testing and controls are utilized and documented A Generate and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables. A Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Software Design Quality Engineering practices. A Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. A Support both internal and external audit activities. A Support other quality projects and initiatives as assigned. QUALITY SYSTEM RESPONSIBILITIES A Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed. A Complete training requirements and competency confirmations as required for this position within the required timeline. A Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement. QUALIFICATIONS Educational Requirements: Required A Bachelors degree in a technical or scientific field. Preferred A Bachelors degree in an engineering discipline such as computer science, electrical, mechanical, software or biomedical. A Masters degree in a technical or scientific field. Keywords: quality analyst information technology microsoft |
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| Wed Nov 29 23:03:00 UTC 2023 |