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 Senior 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 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.

RESPONSIBILITIES

• Assure compliant process conformance and complete product documentation, inclusive of Design History, Product, Process Service documentation, supporting successful and compliant standard and custom product realization.
• Partner with engineering to ensure conformance to requirements of 21 CFR Part 820, ISO 13485 with particular focus on Design Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy, and Security.
• Provide teams with technical support for QA / Regulatory compliance activities.
• Participate in CAPA process, risk analysis, complaint management and internal auditing.
• Guide application of GxP non-product software development and validation under industry standards and regulations, including GAMP, 21 CFR Part 11. 
• Able to identify, develop, and execute process improvements and drive change cross functionally across a multi-client site operation.
• Support internal as well as external audits and other Quality Assurance functions.

• 8 years of experience in a similar QA / Regulatory function with-in a medical device environment, ideally with a focus on software process compliance.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1, and risk management standard ISO 14971.
• Expertise in software development and / or Quality Assurance in medical device, pharmaceutical, or related regulated fields.
• Experience working in a professional services environment, communicating with key level stakeholders from MedAcuity and client management.
• Proficiency with Root Cause analysis and Corrective Actions (CAPAs).

• Certified Quality Engineer preferred and / or Auditor Certification desired.
• Experience interfacing with FDA, ideally pertaining to inspections and submissions.
• Direct experience with requirements development, analysis, verification, and validation.
• Prior work history with software tools such as eQMS and document control systems such as Master Control, Arena, Veeva, etc.

• Bachelor's degree in Computer Science, Electrical Engineering, or other STEM related fields OR equivalent experience.

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.