Senior Design Quality Engineer/ Design Quality Engineer
Healthminds Consulting Pvt Ltd · Bengaluru · onsite · Posted 51d ago
Not disclosed5–7 yrsfulltimeSourced from
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About this role
Senior Design Quality Engineer/ Design Quality Engineer
Roles & Responsibilities
Roles & Responsibilities
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and support Quality Plan design.
- Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system lifecycle.
- Validates key design inputs like usability, reliability, Performance, supportability, manufacturability, localizability, security, Privacy, serviceability, sustainability, and costs.
- Performs assessment of product quality performance and post-market product quality analysis.
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when enquired.
- Ensure compliance requirements are met during design reviews, design Verification, validation, and design transfer.
- Apply and Facilitate design for quality and reliability best practices (FMEA, robust design, V&V, RCA, Problem-solving).
- Bachelor's Engineering degree with 5-7 years of related experience or Master's degree with 3+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering
- Engineering Degree or equivalent experience in the medical device industry
- 3+ years experience with a medical device company preferably
- Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.).
- Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, and Usability.
- Understand Sample Size Determination and Statistical Methods, Safety Risk Management (i.e ISO 14971), and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis.
- Understand a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
- Understand the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
Sourced from foundit
Skills
21 CFR Parts 820Design and UsabilityEU MDRrequirements managementISO 13485Iso 14971Safety Risk ManagementAudit Processfault tree analysisRisk ManagementRCAStatistical MethodsMEDDEVsample size determination
About Healthminds Consulting Pvt Ltd
Healthminds Consulting Pvt Ltd
Pharma
Bangalore / Bengaluru, Karnataka
India
₹5.5L PA avg
Avg at Healthminds Consulting Pvt Ltd
About
HealthMinds Consulting Pvt. Ltd is a Bengaluru-based healthcare consulting firm offering services in medical writing, healthcare data analytics, and public health advisory. Established in 2012, the company supports academia and industry with scientific communication, regulatory documentation, and digital CRO solutions. Its multidisciplinary team blends medical expertise, technology, and analytics to deliver customized healthcare content and research support
Industries
Business DevelopmentConsultingHealth CareWellness
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