Location
India | India
Job description
Job Description
Job TitleDesign Quality EngineerJob Description
Job Title: Design Quality Engineer
KEY AREAS OF RESPONSIBILITIES:
Ensures that appropriate quality, reliability, and Post Market Surveillance (PMS) plans are made and include all stages of the product life cycle.
- 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.
Quality Engineer Products and Systems, 50
- 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 root cause analysis and quality problem solving.
- May also provide other quality engineering support, including assisting organizational units in addressing quality engineering deficiencies.
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Qualified expert who is developing beyond entry level knowledge of the quality engineering field.
- Has working knowledge of products and services.
- Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
- Works on issues where analysis of situation or data requires review of relevant factors.
- Exercises judgement within defined procedures and policies to determine appropriate action.
Education & Training
- Bachelors Engineering degree or equivalent experience
Experience & Background
- Basic understanding of global medical device regulations, requirements, and standards, such as 21
- CFR Parts 803, 806, and 820, ISO13485, and ISO9001 or I EC 62304 and IEC 82304
- 5+ years of experience in a medical device or other regulated industry.
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