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Quality Engineer
Quality EngineerKoch Industries • Naperville, IL, United States
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Quality Engineer

Quality Engineer

Koch Industries • Naperville, IL, United States
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Your Job

Molex's Naperville Printed Circuit Solutions team is looking for a Quality Engineer . The Quality Engineer will work closely with Advanced Quality Planning engineering, Process Engineers, and manufacturing team members to create and maintain a quality plan. This person will also manage and mitigate project risk to ensure a flawless product launch. This person will 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.

To comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and / or the Export Administration Regulations.

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 & 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.

Who You Are (Basic Qualifications)

  • 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%
  • 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
  • For this role, we anticipate paying $80,000 - $105,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.

    At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

    Hiring Philosophy

    All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here .

    Who We Are

    As a Koch company, 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 thousands of innovators who work for Molex have made us a global electronics leader. Our experienced people, groundbreaking products and leading-edge technologies help us deliver a wider array of solutions to more markets than ever before.

    At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

    Our Benefits

    Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation / time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.

    Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

    Equal Opportunities

    Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information. (For Illinois E-Verify information click here , aquí , or tu ).

    #LI-LRT

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    Quality Engineer • Naperville, IL, United States

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