Molex
Molex’s Naperville Printed Circuit Solutions team is looking for a
Quality Engineer
to work closely with Advanced Quality Planning engineering, Process Engineers, and manufacturing team members to create and maintain a quality plan. The role will manage and mitigate project risk to ensure a flawless product launch and support day-to‑day operations with respect to problem solving, customer concern resolution, and quality system‑related assignments.
Location This is an onsite role based at our facility in Naperville, IL.
What You Will Do
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 and necessary statistical analysis with the goal of tool and process qualification. Includes Installation Qualification, Operation Qualification, and Performance Qualification (IQOQPQ), equipment validation, and process validation.
Quality System: Work with all departments to ensure compliance with 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: 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 and systemic improvements to reduce Quality Notifications.
Who You Are (Basic Qualifications)
Bachelor’s Degree in Engineering or 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% of time.
What Will Put You Ahead
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.
Compensation Anticipated pay $80,000 – $105,000 per year, with variable pay eligible.
Benefits Includes medical, dental, vision, flexible spending and health savings accounts, life insurance, short‑term and long‑term disability, retirement plans, paid vacation/time off, educational assistance, and potentially infertility assistance, paid parental leave, and adoption assistance. Eligibility may vary by geographic region.
Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Some offers of employment are conditioned upon successfully passing a drug test. The employer uses E-Verify.
Company Overview Molex is a leading supplier of connectors and interconnect components, driving innovation in electronics and supporting industries from automotive to health care and consumer to data communications. The company emphasizes diversity, empowers employees to perform at their best, and offers a broad range of solutions.
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Quality Engineer
to work closely with Advanced Quality Planning engineering, Process Engineers, and manufacturing team members to create and maintain a quality plan. The role will manage and mitigate project risk to ensure a flawless product launch and support day-to‑day operations with respect to problem solving, customer concern resolution, and quality system‑related assignments.
Location This is an onsite role based at our facility in Naperville, IL.
What You Will Do
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 and necessary statistical analysis with the goal of tool and process qualification. Includes Installation Qualification, Operation Qualification, and Performance Qualification (IQOQPQ), equipment validation, and process validation.
Quality System: Work with all departments to ensure compliance with 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: 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 and systemic improvements to reduce Quality Notifications.
Who You Are (Basic Qualifications)
Bachelor’s Degree in Engineering or 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% of time.
What Will Put You Ahead
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.
Compensation Anticipated pay $80,000 – $105,000 per year, with variable pay eligible.
Benefits Includes medical, dental, vision, flexible spending and health savings accounts, life insurance, short‑term and long‑term disability, retirement plans, paid vacation/time off, educational assistance, and potentially infertility assistance, paid parental leave, and adoption assistance. Eligibility may vary by geographic region.
Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Some offers of employment are conditioned upon successfully passing a drug test. The employer uses E-Verify.
Company Overview Molex is a leading supplier of connectors and interconnect components, driving innovation in electronics and supporting industries from automotive to health care and consumer to data communications. The company emphasizes diversity, empowers employees to perform at their best, and offers a broad range of solutions.
#J-18808-Ljbffr