Senior Software Quality Assurance Specialist
Velsera – Customer Operations /
Senior Software Quality Assurance Specialist
Location: Pune, India
Who are we?
Welcome to the era of Velsera! Seven Bridges, Pierian & UgenTec have combined to become Velsera.
Velsera is the precision engine company. We empower researchers, scientists, and clinicians to drive precision R&D, expand access to, and more effectively leverage analytics at the point of care.
We unify technology-enabled solutions and scientific expertise to enable a continuous flow of knowledge across the global healthcare ecosystem. This interweaves diverse biomedical communities, allowing them to build upon each other’s success and accelerate medical breakthroughs that positively impact human health. With our headquarters in Boston, MA we are rapidly growing and expanding our team which currently has over 800 employees located in 14 different countries!
What is the job?
- This role is responsible for following, executing, and maintaining software quality assurance standards and measures across the organization. This position will apply proven analytical, problem-solving and quality assurance and regulatory compliance skills to maximize the benefit of business investments in software initiatives and ensure products are designed, developed, tested, and manufactured in accordance with applicable regulatory requirements, customer/patient expectations, and best practice industry standards.
What will you do?
- Support all phases of the project life cycle (including, but not limited to requirements development/review/approval, test planning, test execution, and test reporting and assessment)
- Drive, monitor, and review all documentation related to SQA and review activities throughout the project lifecycle
- Monitor and provide regulatory improvement recommendations for test plans through characterization of testing evolutions – system, integration, functional, performance, regression testing, and user acceptance
- Monitor and provide regulatory improvement recommendations for SDLC project deliverables.
- Drive and support routine regulatory compliance reviews with project stakeholders to ensure all deliverables meet all compliance requirements
- Support Principal SQA and SQA manager with the development of best practices to improve efficiency and overall quality of work delivered by project teams
- Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
- Support regulatory inspections related to Software Quality Assurance
- Assist Principal SQA and SQA manager in providing guidance to the team to interpret regulatory requirements for various life-cycle stages
- Participate in the investigation, root cause analysis, corrective and preventive actions through the CAPA lifecycle as applicable; provide guidance to teams to ensure that CAPAs are brought to closure in an appropriate timeframe as dictated by Pierian’s SOP
- Support Principal SQA and SQA manager in driving good documentation practices across the organization
What do you bring to the table?
- 6+ years of software quality assurance (SQA) experience, including experience leading and implementing QA & QC activities using SDLC methodologies (Waterfall, Agile) in a regulatory/compliance environment
- 2+ years of experience with regulated medical device software
- BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent 4-year degree in engineering expertise related to design verification and design validation requirements in the medical device industry (or other highly regulated industry)
- Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices as well as IEC 62304
- Understanding of applicable CFRs for a medical device – 21CFR Part 11 (expertise), 21CFR 800 – 1299 (implementation knowledge)
- Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules
- Ability to constructively collaborate with cross-functional teams
- Software testing experience related to the medical device industry
- Strong knowledge of quality assurance methodologies
- Ability to follow instructions, work independently, or function in a team as needed
- Knowledge of commonly used concepts, practices, and procedures for a full product development lifecycle
- ASQ Certification (i.e., Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager) preferred
- Experience supporting regulatory agency inspections and Notified Body Audits in an SME role
What do we offer?
Velsera stands for a stimulating atmosphere where you can grow your capabilities in an open company culture. We want you to do the work you feel great at, or that you would like to become great at. You’ll work for a mission driven organization that is making a true difference in the scientific and healthcare space.
Next to that, we offer competitive salaries including:
* A full-suite of industry leading benefits (list by location)
* Remote work flexibility
If you feel like this could be the next big thing for you, make sure you’re not going to miss out and have a chat with us!
Our Core Values
People first. We create collaborative and supportive environments by operating with respect and flexibility to promote mental, emotional and physical health. We practice empathy by treating others the way they want to be treated and assuming positive intent. We are proud of our inclusive diverse team and humble ourselves to learn about and build our connection with each other.
Patient focused. We act with swift determination without sacrificing our expectations of quality. We are driven by providing exceptional solutions for our customers to positively impact patient lives. Considering what is at stake, we challenge ourselves to develop the best solution, not just the easy one.
Integrity. We hold ourselves accountable and strive for transparent communication to build trust amongst ourselves and our customers. We take ownership of our results as we know what we do matters and collectively we will change the healthcare industry. We are thoughtful and intentional with every customer interaction understanding the overall impact on human health.
Curious. We ask questions and actively listen in order to learn and continuously improve. We embrace change and the opportunities it presents to make each other better. We strive to be on the cutting edge of science and technology innovation by encouraging creativity.
Impactful. We take our social responsibility with the seriousness it deserves and hold ourselves to a high standard. We improve our sustainability by encouraging discussion and taking action as it relates to our natural, social and economic resource footprint. We are devoted to our humanitarian mission and look for new ways to make the world a better place.
Velsera is an Equal Opportunity Employer:
Velsera is proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.