63 applicants
Abbott · 6 days ago
Software Quality Engineer
United States - Massachusetts - Westford
Full-time
Onsite
Mid Level
$57K/yr - $115K/yr
2+ years exp
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Responsibilities
Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including risk management activities
Guide development and documentation of standard operating procedures, specifications, and test procedures
Support product recertifications
Manage CAPA activities, perform thorough investigations, and implement corrective actions
Work within Agile software development lifecycle framework
Coach and mentor team members on best practices in design quality and testing
Participate in reviews for System and Software requirements, design, and code inspection
Support software change management and overall change management activities
Bring forth ideas supporting continuous improvement and implement quality initiatives
Ensure regulatory compliance and collaborate on audits
Support the establishment of customer and product requirements
Complete document Change Request reviews in a timely manner
Support all Company initiatives and Quality Management Systems
Comply with regulatory requirements and maintain positive communications with stakeholders
Perform other related duties and responsibilities as assigned
Qualification
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Required
Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality
Medical Devices experience is REQUIRED
Experience with ISO 14971 is REQUIRED
Experience ensuring automation frameworks and scripts meet design control requirements
Experience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama
Experience as team-member/lead in Agile SDLC projects/programs
Deep knowledge of various types of SDLC’s (V-Model, Iterative, Agile/Scrum, etc.)
Experience working in a broader enterprise/cross-site business unit model
Working knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to work in a lab, and hands-on experience with medical device development
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Ability to multitask, prioritize and meet deadlines in timely manner
Preferred
Master’s level degree preferred
ASQ CSQE and ISTQB certifications desired
Experience working with test management tools such TestComplete, desired
Experience in code review/static analysis tool(s) to aide code review such as Coverity, desired
Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired
Clinical/Hospital experience desired
Experience in software testing and verification/validation, including lead experience, desired
Benefits
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
Training and career development, with onboarding programs for new employees and tuition assistance
Company
Abbott
Abbott is engaged in pharmaceuticals and manufacturing healthcare products.
10,001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2014-07-14Acquired· by Mylan ($5.3B)
2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
Leadership Team
Miles White
Chief Executive Officer
Robert Ford
President & Chief Executive Officer
Recent News
2024-06-03
thefly.com
2024-06-03
2024-05-31
Company data provided by crunchbase
