Software Quality Engineer

Philips Iberica SAU; Bengaluru; On-site; INR 15,00,000 - 25,00,000; Full time

Job summary

A health technology company is seeking a Software Quality Engineer to ensure quality standards in software development for medical products. The ideal candidate has over 10 years of PQE experience, particularly within the medical industry, and strong knowledge in relevant regulatory standards. This full-time onsite role requires collaboration with cross-functional teams to maintain high quality in software projects.

Qualifications

• Must have experience in handled internal & external audits.
• Guided R&D team for Defects Handling and tracked defects.
• Prepared QMS procedures and Templates are additional advantage.

Responsibilities

• Ensures SW Quality plans include all software life cycle stages.
• Validates key design inputs for software performance.
• Provides oversight of SW Quality Plan execution and Risk Management.

Skills

10+ years of industry experience in PQE

Worked in medical industry product development team

Strong knowledge in QMS 13485

Experience in internal & external audits

Good knowledge in CAPA and Regulatory

Education

B Tech in Computer Science

Tools

ISO 13485

IEC 62304

ISO 14971

Job description

Job Title

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

1. Experience- 10+ years of industry experience in PQE
2. Skills:
3. Worked in medical industry product development team (exp of 3 to 8 years) as QE. SW domain is must.
4. Strong knowledge in QMS 13485, 21 CFR, EU MDR, SW LC 62304, Usability 62366, RMM 14971 and experience in guided R&D team.
5. Heavily involved in all design control doc reviews and maintained DHF.
6. Guided R&D team for Defects Handling and tracked defects.
7. Experience in handled internal & External audits
8. Prepared QMS procedures and Templates are additional advantage.
9. Good knowledge in CAPA, Regulatory, Verification and Post Market Surveillance.

Education

Candidate shall be with B Tech in Computer Science (or) experience as SW Developer

Anything else

• Must following one the skills
• ISO 13485 - Quality management systemsfor 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 role type

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.