- Develop, implement, maintain and improve appropriate quality system elements to ensure a degree high product quality and continuous improvement.
- Provide Quality Engineering support for, NPI, Sustaining activities and improvement projects.
- Own and/or support Quality Notifications (Non-Conformance events), Correction and Preventive Actions (CAPA) as needed and assigned.
- Assess Manufacturing and Design changes against their impact and support the implementation of such changes.
- Support Post Market in the analysis of Complaint data and RMAs Failure Analysis investigation.
- Collect, analyze, and trend product quality data and provide reports to management on progress or escalation.
- Address product quality issues and approve material dispositions.
- Support Internal and External audits.
- Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.
- Interface with other engineering departments, manufacturing sites, customers, and suppliers on quality related issues in a timely manner
- Apply knowledge of process control tools, statistical sampling and other analytical techniques to maximize the quality and flow of product through the production line.
- Identify, analyze, and manage risk through product life cycle with use of risk management tools.
- Troubleshoot equipment, process or material issues and provide resolutions.
- Support projects to support the site manufacturing and quality improvement initiatives.
- Performs other duties assigned as needed.
- Minimum Education: Engineering degrees are preferred in Quality
- 6 years of related work experience in a regulated industry
- Preference for Electro-Mechanical Medical Device experience
- Experience in Quality, Manufacturing, or Research and Development experience in a medical device or other regulated industry.
- Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations (i.e., Root Cause Problem Solving).
- Ability to apply project management skills to ensure fulfillment of new product development requirements.
- Ability to develop and implement Quality standards.
- Demonstrated auditing and problem-solving skills.
- Strong knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
- Ability to effectively communicate with internal and external personnel at all levels of the organization.
- Well-developed influencing and negotiation skills.
- Ability to effectively train and mentor a diverse array of employees at all levels of the organization.
- Strong understanding of Six Sigma and Process Excellence tools and methodologies.
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Quality Engineer - San Jose, United States - Sanmina-SCI
Description
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world.
Job Title: Quality Engineer
Job Purpose:
Ensure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations and defect trends, in accordance with international industry practices and Medical-FDA regulations (ISO 13485, 21CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAs) and implementing actions that generate defect reduction.
Nature of Duties/Responsibilities:
Salary Range(annual): $90,000 - $98,000
In addition, Sanmina Providesa variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business.