At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop software-driven medical devices, robotic technology, embedded systems, and computer vision solutions.
The Principal Quality Assurance Engineer will work cross-functionally throughout the project life cycle with both internal and external clients. Candidate will be adept at mitigating quality risks and ensuring consistent project execution. Candidate will also lead the auditing processes and / or suppliers to ensure quality compliance standards are realized.
Together, we’re pioneering the future of science by developing software products and solutions that enable our partner teams to help save lives.
ESSENTIAL FUNCTIONS
- Assures compliant process conformance and complete product documentation, inclusive of Design History, Product, Process Service documentation, supporting successful and compliant standard and custom product realization.
- Partners with engineering to ensure conformance to requirements of 21 CFR Part 820, ISO 9001, ISO 13485 with particular focus on Design Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy and Security.
- Provides teams with application of SDLC, verification and validation requirements for FDA minor-major level of concern.
- Participate in CAPA process, risk analysis, complaint management and internal auditing.
- Guides application of GxP non-product software development and validation under industry standards and regulations including GAMP, 21 CFR Part 11.
- Experience working in a professional services environment, communicating with key level stakeholders from MedAcuity Software and Client management.
- Able to identify, develop, and execute process improvements and drive change cross functionally across a multi-client site operation.
QUALIFICATIONS
- BS Degree in Computer Science, Electrical Engineering, or other science related fields or equivalent experience.
- Certified Software Quality Engineer (SQA) preferred and / or Auditor Certification desired.
- Experience in Software Development and / or Quality Assurance in medical device, pharmaceutical, or related regulated fields.
Applicants for employment at MedAcuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.
MedAcuity is an equal opportunity employer.
What We Do
MedAcuity is the go-to Boston-based software development firm for leading MedTech and Robotics companies and innovators, large and small. Founded in 2007 by a team of seasoned software engineers, MedAcuity is ISO 13485:2016 certified and has over a decade of experience delivering FDA Class I, II, III and PMA medical device systems.
Working at the intersection of technology and innovation, we offer a combination of strategic consulting and comprehensive software development services to solve incredibly tough product development challenges for our clients. MedAcuity tailors each partnership to offer clients strategic and tactical insight to increase efficiencies, maximize ROI, and produce successful business outcomes.
