Quality Engineer

Koch Business Solutions, LP; Phoenix (AZ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid vacation

Educational assistance

Job summary

Koch Business Solutions, LP in Phoenix, AZ is seeking qualified candidates for a Quality Engineer position. Your role will focus on maintaining the Polymicro Quality Management Systems while ensuring compliance with ISO 9001, ISO 13485, and FDA requirements.

You will lead root cause investigations, interface with various teams, and support Lean/Six Sigma initiatives. Candidates should have a Bachelor's degree in engineering or science and at least two years of relevant experience.

This role offers a robust benefits package including medical, dental, retirement plans, and more.

Qualifications

• Two years or more engineering experience in a manufacturing or industrial environment.
• Experience with ISO 13485 or ISO 9001.
• Knowledge of FDA and 21 CFR 820 quality system requirements.

Responsibilities

• Maintain the Polymicro Quality Management Systems.
• Interface with Engineering, Manufacturing, and Customer Service Groups.
• Lead root cause investigation projects.
• Monitor and report product/process performance metrics.
• Support Lean/Six Sigma initiatives and programs.

Skills

Engineering experience

Supplier quality management

ISO 13485

ISO 9001

Education

Bachelor's Degree in engineering or science

Tools

SAP

Job description

Your Job

Our Phillips Medisize 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, and 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

• Interface with Engineering, Manufacturing and Customer Service Groups
• Review and approve Engineering Drawings and Manufacturing Instructions
• Manage and coordinate the investigation of customer complaints
• Respond to customer issues in a timely and professional manner
• Lead root cause investigation projects
• Interface with customer and third-party auditors to satisfy program requirements of ISO 9001, and ISO 13485
• Author 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
• Develop, implement, and maintain department work instructions
• Actively support Lean/Six Sigma initiatives and programs
• Support product and process validation

Who You Are (Basic Qualifications)

• Bachelor's Degree in engineering or science
• Two (2) years or more engineering experience in a manufacturing or industrial environment
• Experience in supplier quality management
• Experience with ISO 13485 OR ISO 9001

What Will Put You Ahead

• Experience with specialty optical fibers or fiber optic assemblies
• Working knowledge of FDA and 21 CFR 820 US Code Quality System requirements
• Knowledge of SAP

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.

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.