Software Quality Assurance Specialist - CV238

Software Quality Assurance Specialist - CV238

21 Dec

21 Dec



Job Description

Software Quality Assurance Specialist

Location: Pune, India

Job Description

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.

About PierianDx

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 or @PierianDx on Twitter.

Job Responsibilities

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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