Molex · 5 hours ago
Quality Engineer
Molex is a leading supplier of connectors and interconnect components, driving innovation in electronics. The Quality Engineer will work closely with various engineering and manufacturing teams to create and maintain a quality plan, manage project risks, and support day-to-day operations related to quality assurance and customer concerns.
ElectronicsLogisticsManufacturing
Responsibilities
Quality Plan Development: Ensure the project quality plan for new products and product modifications is focused on the voice of the customer, and all project quality deliverables are completed in a timely manner. Understand and apply requirements specific to industries such as medical and automotive
Metrology & Qualification: Facilitate the development of measurement plans/methods and lead the disposition of new products at First Off Tool (FOT) and qualification. Assist plant process engineers in the design of gages and inspection fixtures, Measurement System Analysis (MSA) studies, capability studies & any necessary statistical analysis with the goal of tool and process qualification. This includes Installation Qualification, Operation Qualification, and Performance Qualification (IQOQPQ), equipment validation, and process validation
Quality System: Work with all departments to ensure compliance to ISO13485 and FDA 21 CFR820 requirements. Perform internal audits as required
Customer Concerns: Ensure documentation relating to customer acceptance of new products and product modifications is completed. Provide corrective action reports to customers
Supplier Quality Engineering Functions. Supplier Approval: Review and approve suppliers’ product-specific documentation on new and modified purchased components. Work with suppliers on quality issues to resolution
Problem Solver: Lead problem solving (8Ds), analysis, and resolution of product-related customer complaints or internal quality complaints. Support efforts for the prevention of repeat issues & systemic improvements to reduce Quality Notifications
Qualification
Required
Bachelors Degree in Engineering or other related field
3+ years of Quality Experience in a manufacturing environment
2+ years of experience in medical device manufacturing
Experience interfacing with the FDA in a medical device manufacturing environment
Experience with root cause and corrective action analysis and documentation
Experience working with cross-functional teams
1+ year of knowledge of statistics with Minitab or similar software
Able to travel (domestic and international) 5% - 10%
Preferred
5+ years of experience in Quality Engineering in a new-product introduction environment
5+ years of medical device manufacturing experience
Working knowledge of electronic assembly, testing, molding, stamping, plating, and assembly processes
Experience with Quality Systems (ISO 9001, ISO13485, and/or TS16949) and supplier auditing
Experience with gage and fixture design
Benefits
Medical
Dental
Vision
Flexible spending and health savings accounts
Life insurance
ADD
Disability
Retirement
Paid vacation/time off
Educational assistance
Infertility assistance
Paid parental leave
Adoption assistance
Company
Molex
Molex supplies electronic interconnect solutions and connectivity products for a broad range of industries. It is a sub-organization of Koch, Inc..
Funding
Current Stage
Late StageTotal Funding
unknown2013-09-09Acquired
Recent News
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2025-11-21
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