Medical Device Senior Software Quality Engineer
Company: Reflik
Location: Cambridge
Posted on: June 20, 2022
|
|
Job Description:
OVERVIEW:Be a part of the Quality team at our Healthcare Optics
Research Laboratory and drive Quality for the development of unique
software based biomedical devices in collaboration with world
leading medical institutions. We are seeking an experienced Medical
Device Senior Software Quality Engineer (Sr Engineer, Software
Quality Assurance) who can lead software design assurance and risk
management activities and provide quality support of software
development lifecycle processes and drive
compliance.RESPONSIBILITIES:--- Ensure that software deliverables
including software requirement specifications, software development
plans, software architecture documents, and software verification
and validation plans are compliant to software development
lifecycle process procedures--- Act as a member of Issue Review
Team meetings to ensure that software bugs are evaluated and
addressed appropriately--- Provide guidance on the selection of
statistical analyses and sample size for design verification and
validation and other qualification and acceptance testing---
Support the successful transfer of products to manufacturing by
ensuring the adequacy of process validation, design transfer plans,
quality plans and supplier documentation--- May plan and execute
internal audits against applicable quality system standards,
regulations and internal procedures.QUALIFICATIONS:--- Education:
BS or higher degree in engineering, or similar--- Experience: 5
years minimum experience with a minimum of 3 years of Medical
Device experience and a minimum of 3 years of Quality experience or
design control experience, including experience in leading design
control and risk management activities--- In-depth understanding of
medical device design control and risk management--- Working
knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304,
IEC 60601 and ISO 14971--- Experience with JIRA/JAMA software tools
and their implementation is a plus--- Certification as an internal
lead auditor for QSRs and/or ISO 13485 is a plus--- Skills:
Proficient in Microsoft Office. Experience in Minitab, JMP or
similar statistical packageHYBRID: This position offers a hybrid
work schedule requiring you to be in the office 2 days a week and
an option to work from home 3 day out of the week (unless a
specific business need arises requiring in office attendance on
other days). Note that work schedules and office reporting
requirements may change from time to time based on business
needs.
Keywords: Reflik, Cambridge , Medical Device Senior Software Quality Engineer, Healthcare , Cambridge, Massachusetts
Click
here to apply!
|