Software Quality Engineer

Job Title

Job Description

Job title:
Software Quality Engineer

Your role:

• Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design.
• Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs).
• Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle.
• Can lead quality related problem solving for software.
• Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required.
• Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every milestone.

You're the right fit if: (4 x bullets max)
1. Experience- 10+ years of industry experience in PQE
2. Skills:

• Worked in medical industry product development team (exp of 3 to 8 years) as QE. SW domain is must.
• Strong knowledge in QMS 13485, 21 CFR, EU MDR, SW LC 62304, Usability 62366, RMM 14971 and experience in guided R&D team.
• Heavily involved in all design control doc reviews and maintained DHF.
• Guided R&D team for Defects Handling and tracked defects.
• Experience in handled internal & External audits
• Prepared QMS procedures and Templates are additional advantage.
• Good knowledge in CAPA, Regulatory, Verification and Post Market Surveillance.

3. Education-

Candidate shall be with B Tech in Computer Science (or) experience as SW Developer
4. Anything else-

Must following one the skills

ISO 13485 - Quality management systems for Medical Devices

IEC 62304 - Medical device software — Software life cycle processes

ISO 14971 - Application of risk management to medical devices

IEC 82304 - Health software, Product Safety

IEC 62366-1 - Application of usability engineering to medical devices

EUMDR – European Medical Device Regulation

21CFR – US FDA Medical Regulation

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.