Software Quality Assurance Analyst

Job Description

Who we want:

• The detail-oriented process improves Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.
• Self-directed imitators: People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Meticulous documenters: Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

• Risk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.
• You will be leading Product risk assessment as per ISO14971.
• As a Subject Matter Expert on Design controls, Risk Management you will scope and lead regular software releases to regularly tackle field defects and top customer pain points.
• Provide technical or leadership mentorship to other QEs in the business
• Provide inputs into the design of products in development
• Support validation programs for new product development.
• Responsible for initiating, reviewing (Includes Design reviews & Phase Reviews), documenting, and approving Engineering Change Orders (ECOs).
• Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability.
• Partners with the operations team to develop and maintain a robust internal and external supply chain. Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching.
• Develop procedures for incoming, in-process, and final inspections for new product development.
• Assists and mentors the unit quality engineer in the trending and analysis of quality data (e.g. complaints, Tech Support trouble tickets, Pareto charts, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
• Authors and reviews procedures to ensure GMP and ISO 13485 compliance.
• Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
• Lead product quality-related projects. Supports the business in addressing and solving quality problems.
• Exposure to any Programming language & Software Testing concepts.
• Work with cross-functional/cross-cultural teams to develop regulatory guidelines and procedures.
• Post-Quality Engineering including Complaint Handling, NC, CAPA.
• Provide inputs for NPDP for adherence to QMS and Good Documentation Practices.
• May interact, by telephone or in-person, with customers to resolve product issues as part of the support escalation model.
• May require Visit to clinical facilities and health care providers (HCP) to gather user data to further develop and improve clinical knowledge, use cases, and potential applications for medical devices

What you need:

• 10-14 Years of work experience in the testing & Quality Assurance domain.
• Education: BE/BTech or Equivalent Software or Electronics/Electrical (Preferably Software) with experience in a quality role in engineering /manufacturing environment
• Sound knowledge of IEC 62304: Medical device Software Software life cycle processes. This also includes good exposure to all the phases of the Software development life cycle (SDLC).
• Exposure to Software development life cycle & validation process.
• Able to do a risk assessment for medical devices as per ISO 14971.
• Knowledge of IEC 62304 standard for Medical device software.
• Knowledge of IEC 606061-1 family of standards will be a plus.
• Knowledge of Human Factors Engineering/ Usability Engineering IEC62366.
• Strong understanding of Quality Management Systems for Medical Devices.
• Champion for Corrective Action and Preventative Action (CAPA) process.
• Excellent analytical skills.
• Strong experience in Documentation, Review & Reporting areas.
• Excellent interpersonal communication skills.
• Demonstrated ability to test, review defects, and inspect software codes.
• Demonstrated software or electrical problem-solving skills.
• Troubleshooting and Root cause techniques

Keyskills :
life cyclechange ordersiec 62304product qualityrisk managementsoftware testinguse casessupplier auditscontinuous improvement facilitationwork processesproblem solvingproduct safetypareto chartsiso 13485quality assuranceroot causemedical de