Quality Engineer

Your Job

Our Costa Mesa, CA facility is seeking a Quality Engineer to support manufacturing of injection molded parts and assembly.

Our Team

Phillips Medisize, a Molex Company is an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.

What You Will Do

• Use quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques
• Assist the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
• Monitor production processes and products for adherence to company and regulatory standards and practices
• Participate in quality improvement initiatives and projects
• Perform quality reviews and internal audits; evaluate data and write reports to validate or indicate deviations from existing standards
• Review and approve change requests
• Manage the qualification of processes performed by suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
• Facilitate communication between engineering, manufacturing, and quality functions
• Responsible for being a communication liaison between the customer and manufacturing facility
• This role requires up to 20% international travel

Who You Are (Basic Qualifications)

• Bachelor's Degree in an Engineering Field or 5 + years of direct Quality experience
• At least 1+ years Quality/Regulatory experience
• Legally authorized to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship

What Will Put You Ahead

• Auditing experience preferred
• Knowledge of injection molding
• Experience working with an ERP system (SAP)

For this role, we anticipate paying $70,000 - $95,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.

This role is not eligible for VISA Sponsorship.

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

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world's largest privately held companies. Discover your potential to make a difference.

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, aqui, or tu).

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