Job Title
Quality Engineer
Job Description
The Quality Engineer-Products and Systems is a key member of our Sleep & Respiratory Care, Quality organization, accountable for ensuring our Sleep & Respiratory Care products are protected and compliant with Internal/External regulations, requirements and standards
Your role:
- Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone. Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
- Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle.
- Performs independent technical assessment on product quality performance and post‐market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required.
- Supports stakeholders during the execution of quality system‐and product audits and inspections. Provide quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
- Ensures that appropriate Quality, Reliability‐and Post Market Surveillance (PMS) plans are made and include all stages of the product life cycle
You're the right fit if:
- You have a minimum of 8+ years’ experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality/Control, working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.
- You have experience independently producing and completing quality engineering documents, performing timely quality engineering tasks including assessing quality plans, assessing produ
📌 Quality Engineer (Pune)
🏢 Philips
📍 Pune