QMS

Virtusa is a global product and platform engineering services company that makes experiences better with technology. We help organizations grow faster more profitably and more sustainably by reimagining enterprises through domain-driven solutions. We combine strategy design and engineering backed by unmatched expertise at the intersection of industry business and technology to generate real-world business impact for clients. Headquartered in Massachusetts with global delivery centers Virtusa provides a broad range of services solutions and assets including strategy and design AI advisory and services digital engineering data and analytics digital assurance cloud and security cx transformation and managed services across industries such as financial services healthcare communications media entertainment travel manufacturing and technology.

KEY RESPONSIBILITIES
QMS Assessment & Implementation Support
Conduct gap analyses of current QMS processes against ISOCFR Part 820 and EU MDR requirements under the guidance of Senior BAs and QA leadership
Support documentation of QMS processes SOPs work instructions forms and quality records across design manufacturing and post-market phases

Experience
8 years of experience in Business Analysis Quality Assurance or Regulatory Affairs within the medical device industry
Minimum 5 years of direct involvement in QMS implementation documentation or compliance activities for regulated medical devices
Experience working on Class II or Class III medical device programs in FDA and/or EU regulatory environments
Exposure to SaMD (Software as a Medical Device) or connected device programs is advantageous

Technical Standards Knowledge
ISO- Working knowledge; experience applying requirements across QMS processes
21 CFR Part 820 - Familiar with FDA QSR structure design controls and DHF expectations
EU MDR 2017/745 - Basic to intermediate understanding; experience contributing to Technical Files
IEC 62304 - Exposure to software lifecycle documentation and classification
IECAwareness of health software requirements
IECFamiliarity with usability engineering deliverables
ISO/ ISO- Understanding of risk management processes and documentation

Certifications (Preferred)
CCBA or CBAP (Certification in Business Analysis / Certified Business Analysis Professional)
RAPS RAC (Regulatory Affairs Certification)
ISO 13485 Internal Auditor or Lead Auditor
ASQ CQPA or CQE (Quality Process Analyst / Quality Engineer)

Employment Type : Full Time
Experience: years
Vacancy: 1