Your Job
Our Costa Mesa, CA facility is seeking a Quality Engineer to support the manufacturing of injection molded parts and assembly operations. We are seeking a quality professional who can provide strong technical leadership, drive root cause investigations, and support continuous improvement initiatives in a regulated manufacturing environment.
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 testing, design of experiments (DOE), statistical process control (SPC), gauge R&R, and trend analysis
- Lead and facilitate root cause investigations and corrective action activities
- Assist in the development of Quality Management System (QMS) deliverables and APQP activities, including complaint analysis, risk analysis, FMEA, CAPA, and process/equipment/software verification and validation
- Monitor production processes and products for adherence to company and regulatory standards
- Participate in and lead quality improvement initiatives and projects
- Perform quality reviews and internal audits; evaluate data and prepare technical reports
- Review and approve change requests
- Manage supplier quality activities, including process qualification, corrective actions, and supplier performance improvement
- Facilitate communication between engineering, manufacturing, and quality functions
- Serve as a liaison between customers and the manufacturing facility on quality-related matters
Who You Are (Basic Qualifications)
- Bachelor's degree in Engineering OR 4+ years of Quality Engineering experience
- Experience working in a manufacturing environment
- Experience leading root cause investigations and problem-solving initiatives
- Legally authorized to work permanently in the United States for any employer without requiring visa sponsorship or transfer
What Will Put You Ahead
- 10+ years of engineering and/or quality engineering experience
- Experience managing FDA inspections, audits, and regulatory interactions
- Strong technical writing experience
- Experience interfacing directly with customers
- Experience reading and interpreting technical drawings
- Knowledge of injection molding processes
- Experience with ERP systems (SAP preferred)
- Experience in regulated medical device manufacturing environments
For this role, we anticipate paying $80,000- $110,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.
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
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, aquí, or tu).
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