Software Quality Assurance Specialist
Location: Pune, India
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.
Every year millions of people bet their lives on precision medicine.
PierianDx is on a mission to make sure that bet pays off. At PierianDx we empower progressive health institutions and diagnostic laboratories to build world-class precision medicine programs. Our industry-leading molecular genomics technologies and expertise deliver the most integrated, trusted, and collaborative approach across the clinical care spectrum. From genomic sequencing and biomedical informatics in the laboratory to reporting and decision support at the patients bedside, we drive the adoption of genomics in clinical care and accelerate the fight against cancer and other diseases. For more information, visit www.pieriandx.com or @PierianDx on Twitter.
Participate in all phases of the project life cycle (e.g. requirements development/review/approval, test planning, test execution, and test reporting and assessment
Plan, drive, and review all documentation related to SQA and testing deliverables throughout the project lifecycle
Monitor and provide regulatorily improvement recommendations for test plans through characterization of testing evolutions system, integration, functional, performance, regression testing, and user acceptance
Monitor and provide regulatorily improvement recommendations for SDLC project deliverables.
Implement and drive routine regulatory compliance reviews with project stakeholders to ensure all deliverables meet all compliance requirements
Partner with R&D; Software and IT to develop standards and best practices to improve efficiency and overall quality of work delivered by the project team
Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
Serve as Subject Matter Expert for regulatory inspections related to Software Quality Assurance
Providing guidance to the team to interpret regulatory requirements for various life-cycle stages of the project
Participate in the investigation, root cause analysis, corrections, and corrective actions through the CAPA lifecycle as applicable
Drive Good Documentation practices
Act as SME for driving regulatory compliance in the project and participate in audits as applicable
Required Skills and Experience
Experience with Regulated Medical Device Software
3 years of experience designing and leading software quality activities (e.g. automated testing, unit testing, integration testing, test case management, smoke tests, etc)
Demonstrated ability to act as Subject Matter Expert related to Medical Device Quality Assurance
Experience supporting regulatory agency inspections and Notified Body Audits in an SME role
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)
BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree in engineering or demonstrated expertise related to design verification and design validation requirements in the medical device industry or other highly regulated industry
Good to have :
3 years in implementing QA & QC activities using SDLC methodologies (Waterfall, Agile) in a regulatory/compliance environment
3 years of medical device experience
ASQ Certification (Certified Quality Engineer)
Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules
Able to constructively collaborate with cross-functional teams
Working 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 life-cycle and Medical Device Quality Management System.
Perks of working with PierianDx:
Outstanding career development and learning opportunities
Competitive compensation depending on experience and skill
Friendly team and enjoyable working environment
Flexible working schedule
Corporate and social events.
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