Fiberguide, a Molex company, is a dynamic and growing company who specializes in customized multimode fiber optics and assemblies.
Our Molex facility in Phoenix, AZ is currently seeking qualified candidates for our Quality Engineer position. The Quality Engineer maintains the Polymicro Quality Management Systems by developing, implementing, and improving the Quality System to satisfy both internal and external customers, while maintaining compliance with ISO 9001, ISO 13485, & FDA regulatory requirements as well as supports the Production Quality functions to ensure that established level of product quality is maintained.
What You Will Do In Your Role
- Interface with Engineering, Manufacturing and Customer Service Groups
- Perform Supplier Evaluation by conducting on -boarding evaluations, supplier audits, and monitoring product quality
- Conduct testing for quality of finished products as needed
- Coordinate the activities of the Internal Process Audit program and perform the Internal Audit as scheduled
- Review and approve Engineering Drawings and Manufacturing Instructions
- Conduct periodic Gage R & R’s as needed
- Manage and coordinate the investigation of customer complaints
- Respond to customer issues in a timely and professional manner
- Interface with customer and third-party auditors to satisfy program requirements of ISO 9001, and ISO 13485
- Author, update and, Quality System procedures, work instructions and documents to ensure that the resulting processes and products comply with the applicable requirements of ISO 9001, ISO 13485, 21 CFR 820, EU MDR, and current Good Manufacturing Practices
- Monitor and report product/process performance metrics to Management on a quarterly basis
- Ensure robust application of the quality system in standardization programs and maintain compliance to standards of the Quality Management systems that are in place
- Develop, implement, and maintain department work instructions
- Actively support Lean/Six Sigma initiatives and programs
- Understand, support and contribute to current Molex Total Quality Management (TQM), Six Sigma, International Standards Organization (ISO) and Environmental, and/or Health and Safety (EH&S) Management Systems by following stated policies and procedures
- Reviewing and Approving Cleanroom and Gowning Room Environmental records
- Oversee Sterilization Process Requalification, as well as request an internal review of the sterilization process by Sterilizer
The Experience You Will Bring
- Bachelor’s Degree in engineering
- Engineering experience in a manufacturing or industrial environment
What Will Put You Ahead
- Experience with either ISO 9001 or ISO 13485
- Experience with specialty optical fibers or fiber optic assemblies
- Knowledge of DOE and Regressions Analysis
- Knowledge of SAP
- Working knowledge of FDA and 21 CFR 820 US Code Quality System requirements
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.
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.
Equal Opportunity Employer, including disability and protected veteran status.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.
This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf