Quality Engineer

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

About the role

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.

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.

Responsibilities

• 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

Requirements

• 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

Qualifications

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

Pay

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.

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.

• Medical, dental, vision, flexible spending and health savings accounts
• Life insurance, ADD, disability, retirement
• Paid vacation/time off, educational assistance
• May 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.