Summary Of Key Responsibilities
Provide software quality assurance review, subject matter expertise, and support to product development teams, operations, and information systems in support of corporate production and quality objectives.
Serve as Quality core team member on project teams
This role requires strong communication, interpersonal, and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.
Provide quality oversight to Software Development and Verification &Validation teams
Creation, review, and approval of quality and project deliverables based on procedural requirements: Design History File Documents, Software Development records, Verification &Validation records, Design Input Documents
Ensure compliance to established process controls (including Design Controls, Risk Management) throughout software lifecycle
Creation, review and approval of quality system and product-related Change Records
Develop and maintain quality records, procedures, and documents
Support investigations of NC and CAPA as related to software, product, and QMS issues
Provide support for continuous improvement projects to advance processes and capabilities
Work with key partners to ensure awareness and adherence to policy and procedures
Develop and deliver training to employees on software validation, software risk management, and general quality tools
Monitor quality metrics, analyze trends, and work with manager to develop action plans
Ensure audit readiness, and represent area as a subject matter expert
Provide Quality management with status updates on assigned responsibilities and goals
Manage post market surveillance and product complaint handling
Qualifications and Skills
Experience working with Corrective Action/Preventive Action, and thinking outside the box in order to ensure Product Development deliverables are created and other aspects of the QMS are defined and executed per the project’s Quality Plan
4+ years Software Quality Engineering or relevant experience
Experience in FDA regulated environment, software as a medical device preferred
Experience with Design Controls and Risk Management for Medical Devices
Working knowledge of applicable standards and regulations, including 21CFR Part 820, ISO 13485, 14971, FDA’s General Principles of Software Validation, IEC 62304
Understanding of Software Development Lifecycle
Knowledge of custom software code development V&V
Ability to read, interpret, and implement regulatory documents, procedures, and reports
Previous experience developing QMS procedures, Quality Plans, Risk Assessments, CAPA
Experience working in a professional software development environment: formal QA, best practices for schedules, processes, defect identification and resolution, version control, build management
Familiarity with Waterfall/Hybrid/Agile/SCRUM/etc methodology
Ability to communicate effectively with internal customers, supervisor, team
Ability to effectively compose reports, work instructions, procedures, training
Adaptable to fast-paced, dynamic work environment with shifting demands
The statements herein describe the general nature and level of work being performed by employees assigned to this position and should not be construed as an exhaustive list of all responsibilities, duties, and skills required or assigned
TRAVEL: Ability to travel up to 30% of the time as needed
Certifications and/or Licensure
Software certifications (ASQ CSQE) preferred
Education and/or Experience
Bachelors degree in Engineering, Computer Science, Sciences
Equivalent combination of experience and/or education may be considered
Computer Skills
To perform this job successfully, an individual should have knowledge of Microsoft software applications, internet capabilities, virtual team applications. Excellent computer skills, including Word, Excel, PowerPoint, gSuite,
Physical Demands/Work Environment
While performing the duties of this Job, the employee may be regularly required to sit;stand or remain stationary for extended periods of time and use hands and fingers as well as talk and hear. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.
Requirements for Remote Work:
A quiet workplace to perform work duties and participate in virtual meetings
Must live in a location that can leverage an existing reliable high-speed internet and phone service
Minimum upload speed 5 MB/s, preferred upload speed 25 MB/s
Minimum download speed 25 MB/s, preferred download speed 50 MB/s
Candidates must provide and meet all technical requirements prior to the first day of work
Provide software quality assurance review, subject matter expertise, and support to product development teams, operations, and information systems in support of corporate production and quality objectives.
Serve as Quality core team member on project teams
This role requires strong communication, interpersonal, and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.
Provide quality oversight to Software Development and Verification &Validation teams
Creation, review, and approval of quality and project deliverables based on procedural requirements: Design History File Documents, Software Development records, Verification &Validation records, Design Input Documents
Ensure compliance to established process controls (including Design Controls, Risk Management) throughout software lifecycle
Creation, review and approval of quality system and product-related Change Records
Develop and maintain quality records, procedures, and documents
Support investigations of NC and CAPA as related to software, product, and QMS issues
Provide support for continuous improvement projects to advance processes and capabilities
Work with key partners to ensure awareness and adherence to policy and procedures
Develop and deliver training to employees on software validation, software risk management, and general quality tools
Monitor quality metrics, analyze trends, and work with manager to develop action plans
Ensure audit readiness, and represent area as a subject matter expert
Provide Quality management with status updates on assigned responsibilities and goals
Manage post market surveillance and product complaint handling
Qualifications and Skills
Experience working with Corrective Action/Preventive Action, and thinking outside the box in order to ensure Product Development deliverables are created and other aspects of the QMS are defined and executed per the project’s Quality Plan
4+ years Software Quality Engineering or relevant experience
Experience in FDA regulated environment, software as a medical device preferred
Experience with Design Controls and Risk Management for Medical Devices
Working knowledge of applicable standards and regulations, including 21CFR Part 820, ISO 13485, 14971, FDA’s General Principles of Software Validation, IEC 62304
Understanding of Software Development Lifecycle
Knowledge of custom software code development V&V
Ability to read, interpret, and implement regulatory documents, procedures, and reports
Previous experience developing QMS procedures, Quality Plans, Risk Assessments, CAPA
Experience working in a professional software development environment: formal QA, best practices for schedules, processes, defect identification and resolution, version control, build management
Familiarity with Waterfall/Hybrid/Agile/SCRUM/etc methodology
Ability to communicate effectively with internal customers, supervisor, team
Ability to effectively compose reports, work instructions, procedures, training
Adaptable to fast-paced, dynamic work environment with shifting demands
The statements herein describe the general nature and level of work being performed by employees assigned to this position and should not be construed as an exhaustive list of all responsibilities, duties, and skills required or assigned
TRAVEL: Ability to travel up to 30% of the time as needed
Certifications and/or Licensure
Software certifications (ASQ CSQE) preferred
Education and/or Experience
Bachelors degree in Engineering, Computer Science, Sciences
Equivalent combination of experience and/or education may be considered
Computer Skills
To perform this job successfully, an individual should have knowledge of Microsoft software applications, internet capabilities, virtual team applications. Excellent computer skills, including Word, Excel, PowerPoint, gSuite,
Physical Demands/Work Environment
While performing the duties of this Job, the employee may be regularly required to sit;stand or remain stationary for extended periods of time and use hands and fingers as well as talk and hear. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.
Requirements for Remote Work:
A quiet workplace to perform work duties and participate in virtual meetings
Must live in a location that can leverage an existing reliable high-speed internet and phone service
Minimum upload speed 5 MB/s, preferred upload speed 25 MB/s
Minimum download speed 25 MB/s, preferred download speed 50 MB/s
Candidates must provide and meet all technical requirements prior to the first day of work