Quality Engineer I - Remote
United States of America
Full-time
2 weeks ago
$30 USD
No H1B
Key skills
Medical device experienceQuality system designRisk management processesLean Six SigmaDesign controlStatistical analysisTeam collaborationProblem solvingCommunication skillsLeadershipRisk Management
About this role
Kelly Science, Engineering, Technology & Telecom is seeking a remote Quality Engineer I. The role focuses on leading activities that support new product development and existing products/processes, ensuring compliance with quality system requirements, and providing general QA support to manufacturing facilities.
Responsibilities:
- Support corporate Human Resources Development and Diversity policy
- Manage self/team in alignment with IDEAL behaviors
- Understand Global Quality Objectives and Team Strategies
- Provide technical leadership in solving quality-related technical problems
- Develop and implement new quality concepts, tools, and strategies
- Solve technical problems and consult on issues/projects as a Subject Matter Expert
- Understand complaint trends and reduction strategies by product family
- Participate in/facilitate deliverables for medical device change control and product development
- Engage in product development plans, focusing on design reviews, quality plans, design transfer, and design verification/validation
- Direct activities to achieve design control and change control deliverables related to product safety and performance
- Ensure compliance with risk management requirements
- Collaborate with cross-functional teams to determine root causes and mitigations for product issues
- Develop statistical plans for change control and design control activities
- Apply Lean Six Sigma concepts to address product/process nonconformance issues
- Lead or participate in monthly complaint review meetings
- Lead GPMS Reviews reports data compilation and analysis
- Participate in risk analysis on incident escalations to management
- Engage in internal and external audits as needed
Requirements:
- Must be able to support EST hours (M-F 8am-5pm)
- B.S. in Engineering, Science, or Statistics
- Minimum of 5 years of experience in product development and quality in a medical device environment
- Minimum of 3 years of experience developing and improving product development processes
- Experience with quality system design related to design control or risk management processes ISO 14971
- Proficiency in medical device GxP ISO Standards
- Demonstrated proficiency in product/process/system validations, design control, and risk analysis/assessments
- Six Sigma Black Belt
- Lean Enterprise
- Design for Six Sigma