What are the responsibilities and job description for the Quality Engineer position at Mannara Technologies Pvt. Ltd.?
Job Title: Quality Engineering - Engr II
Location: Irvine, CA, 92614
Duration: 12 Months Contract (Good Possibilities of extension)
Job Description:
How you will make an impact:
- Perform Quality Engineering activities related to product development and existing product support
- Ensure NPD processes comply to quality system and applicable regulatory standards.
- Conduct DHF gap assessment to identify and assess risks. Develop and implement effective mitigation strategies to address risks.
- Remediate risk management and design control files. Maintain relevant quality documentation.
- Develop and execute test methods validations and qualification plans.
- Support design change and facilitate process transfer from development to production.
- Assist with non-conformance resolution.
- Analyze complaints and conduct Benefit-Risk assessment.
- Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing.
- Other duties assigned by Leadership.
What you'll need (Required):
- Bachelor’s degree in engineering required
- 2-4 years' experience required
What else we look for (Preferred):
- Relevant experience in product development, quality assurance, and/or related fields
- Knowledge and understanding of Engineering and Quality principles, theories, and concepts
- Understanding of ISO 13485
- Experience developing, updating, and maintaining technical content of risk management files
- Print reading skills
- Understanding of statistical techniques. Experience using statistical software (Minitab, JMP) a plus. CAD experience (SolidWorks -or- Creo) a plus
- Experience in test method development including validation and/or fixture development
- Understanding of medical device operations and/or manufacturing processes
- Solid problem-solving, organizational, analytical, and critical thinking skills
- Good documentation, communication (e.g., written and verbal) skills
- Ability to build productive working relationships and interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast-paced environment.
