Quality Assurance Specialist
4 weeks ago
As a Quality Engineer at Molex, you will play a critical role in maintaining the company's quality management systems. Your primary responsibility will be to develop, implement, and improve the Quality System to satisfy both internal and external customers, while maintaining compliance with ISO 9001, ISO 13485, and FDA regulatory requirements.
Key Responsibilities
Interface with Engineering, Manufacturing, and Customer Service Groups to ensure seamless communication and collaboration.
Perform Supplier Evaluation by monitoring product quality and implementing corrective actions as needed.
Coordinate testing for quality of finished products and review and approve Engineering Drawings and Manufacturing Instructions.
Manage and coordinate the investigation of customer complaints and respond to customer issues in a timely and professional manner.
Lead root cause investigation projects and interface with customer and third-party auditors to satisfy program requirements of ISO 9001 and ISO 13485.
Create and update 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 and develop, implement, and maintain department work instructions.
Actively support Lean/Six Sigma initiatives and programs and review and Approve Cleanroom and Gowning Room Environmental records.
Oversee Sterilization Process Requalification and support product and process validation.
Requirements
Bachelor's Degree in engineering or science.
Engineering experience in a manufacturing or industrial environment.
Experience with either ISO 9001 or ISO 13485 and knowledge of DOE and Regressions Analysis.
Working knowledge of FDA and 21 CFR 820 US Code Quality System requirements and knowledge of SAP.
About Molex
Molex is a global team of innovators who design and create solutions for businesses where data, technology, and the complex electronic solutions that harness them are being transformed by rapid change. We are part of a team around the globe working to improve life's essential products like food, clothing, water, transportation, medical, and technology. We design, develop, and create innovative and life-changing medical technologies for millions of people around the globe. 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.
Benefits
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.
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