Respironics Inc
Location
Pune | India
Job description
Job title:
Design Quality Engineer
Your role:
Produces and Completes Quality Engineering documents under direct supervision.
Responsible for performing timely, detailed quality engineering tasks like: assessing product designs and reviewing test and other performance data, analyses market feedback, completing or assisting with in root cause analysis and quality problem-solving.
May also provide other quality engineering support, including assisting organizational units in addressing units in addressing deficiencies.
Works on issues where analysis of situation or data requires review of relevant factors.
Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.This is in close collaboration with main stakeholders like 'R&D' engineers,PMS investigators, Risk Managers,Regulatory Affairs specialists, Product Industrialization Engineers, Reliability Engineers etc.
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
Supports stakeholders during the execution of quality system- and product audits and inspections.
Within NPI and Sustaining Projects supports all ongoing Project activities e.g. coordinates Quality Norm planning activities, reviews and approves design deliverables and guides the Project Team regarding open Process/Quality questions.
Identifies the problem and some relevant issues in deviating situations, analyses each, using standard procedures, and co-decides.
Oversight of product reliability and FMEA activities
You're the right fit if: (4 x bullets max)
1. Experience- 6+ years of experience in Medical device or regulated device industry
2. Skills- Basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485. ISO 14971 and IEC 60601 standards
3. Education- Bachelor's engineering degree or equivalent experience
4. Anything else- Preferred candidate from healthcare background.
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