Quality Engineer
Molex is seeking a Quality Engineer for our Hudson, WI site — a focused, fast-moving facility that serves the rapidly growing Optical Connectivity business through New Product Introduction (NPI) and volume production.
About the Role
In this role you will lead product quality and validation activities throughout new product introduction, support and gather valuable process data to aid in volume production improvements, and serve as the key link between customers and manufacturing. You will support the quality department in a scaling manufacturing environment that produces high-quality optical connectivity products employing fiber termination, die cutting, surface mount electronics, and light assembly technologies. The site offers end-to-end NPI industrialization, high-speed manufacturing capabilities, and serves as a global Center of Excellence for process and automation technologies.
At Molex, our goal is to create value for others. We empower every team member to hear, feel, and see the quality in every action we take. By incorporating quality into the design of products, processes, and predicting potential quality problems before manufacturing and delivering the product, we can create mutual benefit. The leading task of quality control involves enforcing the use of specified processes and materials, ensuring the qualification of operators and equipment, and making a series of planned measurements to determine if quality standards are being met.
Responsibilities
- Lead AQP processes, develop product quality criteria, and execute associated deliverables during new product introduction.
- Serve as a communication liaison between the customer and manufacturing facility.
- Coordinate and lead Process Validation projects for assembly and inspection equipment and associated processes.
- Create validation documentation and oversee validation executions.
- Establish Bill of Materials, control prints, drawings, product specifications, and test methods.
- Coordinate quality system deliverables inclusive of quality events, deviations, MRBs, CAPAs, Batch Records, Inspection Plans, and Certificates of Compliance.
- Establish quality system deliverables inclusive of quality events, deviations, MRBs corrections, CAPAs, Batch Records, and Certificates of Compliance.
- Lead CAPA investigations and outcomes using data-based, structured problem-solving methodology.
- Ensure adherence with customer Quality Agreements and other requirements.
- Implement systems and procedures that assure compliance with Quality and Validation standards. Share best practices and suggest improvement opportunities.
- Development and implementation of statistical incoming and in-process sampling/control plans.
Requirements
- Bachelor’s Degree OR 4+ years of direct Quality or Validation experience.
- 2+ years experience working in a manufacturing environment; high volume or NPI experience preferred.
Qualifications
- Experience with FDA, international regulations, and/or ISO standards.
- Experience navigating and participating in customer or regulatory body audits.
- Associates degree or higher.
- Knowledge of current good manufacturing practice (cGMP).
- Knowledge of quality tools, such as SPC, design of experiment (DOE), root cause analysis.
- Experience with SAP.
- Excellent communication skills and the ability to effectively present information and respond to questions from managers, sales, and customers.
Pay
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.
This position is not eligible for VISA Sponsorship. In order 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.