Quality Engineer/ Sr. Quality Engineer- Software

Roles and Responsibilities
Advanced Quality Engineer shall develop the overall quality approach for new products and line extensions within the new product development and specials process. This includes quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer while working with Regulatory Affairs Department to ensure compliance to FDA Quality System Regulations and ISO 13485.

Risk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.
Sound knowledge of IEC 62304: Medical device Software Software life cycle processes. This also includes good exposure to all the phases of Software development life cycle (SDLC).
Product risk assessment as per ISO14971.
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 & on Software Testing concepts.
Work with cross-functional/cross cultural teams to develop regulatory guidelines and procedures.
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 support escalation model.
May require Visit to clinical facilities and health care providers (HCP) to gather use data to further develop and improve clinical knowledge, use cases, and potential applications for medical devices

1.4 Desired Profile

Education: BE/BTech or Equivalent Software or Electronics/Electrical (Preferably Software) with experience in quality role in engineering /manufacturing environment
Experience: 3 – 6 Years as Quality Engineer / Sr. Quality Engineer

Exposure to Software development life cycle & validation process.
Able to do 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.
Understanding of Quality Management Systems for Medical Devices.
Participant and/or 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.

Employer: Stryker Global Technology Center Pvt Ltd
Salary: ₹ best in the industry
Industry: Other
Location: Delhi NCR

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