Philips

9 hours ago

Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 9 hours agoStatus: Live

Job Summary

Ensure Philips Sleep & Respiratory Care products are safe and compliant by supporting quality plan design across hardware and software milestones, validating critical design inputs, and overseeing quality and reliability execution through the product/system lifecycle. Conduct independent technical assessments and post-market quality analysis to drive root-cause problem solving, support quality system and product audits, and make sure Quality, Reliability, and Post Market Surveillance plans cover every life-cycle stage.

Location: Pune

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Support quality plan design for hardware and software, validating design inputs such as usability, reliability, performance, safety, security, privacy, serviceability, sustainability, and costs.
•Provide oversight of quality, reliability, PMS plans, risk management activities, and design-related work across the product/system lifecycle.
•Perform independent technical assessments and post-market quality analysis to lead quality problem solving and root cause analysis; initiate field actions when required.
•Support stakeholders in executing quality system and product audits and inspections, including helping resolve quality engineering deficiencies.
•Ensure appropriate Quality, Reliability, and Post Market Surveillance (PMS) plans are created and cover all stages of the product life cycle.

Travel: Low travel

Pay and Benefits

Salary: USD 97,440 - 155,904 annually

Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

•8+ years of Quality Engineering experience in FDA-regulated medical device environments, focused on Design Quality/Control.
•Working knowledge of Risk Management (ISO 14971) and global medical device regulations, requirements, and standards.
•Experience independently producing quality engineering documents and completing quality engineering tasks like assessing quality plans and reviewing test/performance data.
•Understand Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803/806/820) and medical device process requirements.
•Bachelor’s degree in Engineering, Quality, or related disciplines; ASQ certifications (CQE, CQA) and/or DfSS Green/Black Belt preferred.

Experience:8+ yearsMedical devicesFDA regulatedMedical deviceQuality engineering

Education:Bachelor's in Engineering, Quality or related disciplines

Skills:Quality problem solvingRoot cause analysisStakeholder supportAudit supportOversight

Certifications:ASQ Certified Quality Engineer (CQE)ASQ Certified Quality Auditor (CQA)DfSS Green BeltDfSS Black Belt

Tech Stack:FDAISO 14971ISO 9001ISO 1348521 CFR Part 80321 CFR Part 80621 CFR Part 820

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

Loading job details...

Preparing the role view and application actions.

Philips

9 hours ago

Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 9 hours agoStatus: Live

Job Summary

Location: Pune

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Support quality plan design for hardware and software, validating design inputs such as usability, reliability, performance, safety, security, privacy, serviceability, sustainability, and costs.
•Provide oversight of quality, reliability, PMS plans, risk management activities, and design-related work across the product/system lifecycle.
•Perform independent technical assessments and post-market quality analysis to lead quality problem solving and root cause analysis; initiate field actions when required.
•Support stakeholders in executing quality system and product audits and inspections, including helping resolve quality engineering deficiencies.
•Ensure appropriate Quality, Reliability, and Post Market Surveillance (PMS) plans are created and cover all stages of the product life cycle.

Travel: Low travel

Pay and Benefits

Salary: USD 97,440 - 155,904 annually

Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

•8+ years of Quality Engineering experience in FDA-regulated medical device environments, focused on Design Quality/Control.
•Working knowledge of Risk Management (ISO 14971) and global medical device regulations, requirements, and standards.
•Experience independently producing quality engineering documents and completing quality engineering tasks like assessing quality plans and reviewing test/performance data.
•Understand Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803/806/820) and medical device process requirements.
•Bachelor’s degree in Engineering, Quality, or related disciplines; ASQ certifications (CQE, CQA) and/or DfSS Green/Black Belt preferred.

Experience:8+ yearsMedical devicesFDA regulatedMedical deviceQuality engineering

Education:Bachelor's in Engineering, Quality or related disciplines

Skills:Quality problem solvingRoot cause analysisStakeholder supportAudit supportOversight

Certifications:ASQ Certified Quality Engineer (CQE)ASQ Certified Quality Auditor (CQA)DfSS Green BeltDfSS Black Belt

Tech Stack:FDAISO 14971ISO 9001ISO 1348521 CFR Part 80321 CFR Part 80621 CFR Part 820

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn