Job Description

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.