NPI Quality Engineer
Phillips-Medisize is seeking a motivated and self-driven NPI Quality Engineer to join our team in Costa Mesa, CA. The Quality Engineer is a member of the Quality Assurance Team and is responsible for planning and conducting activities concerned with the quality assurance systems. Additionally, this role will support the development, validation and manufacturing of injection molded parts and assembly.
What You Will Do In Your Role
- Lead the process that monitors manufacturing improvements to measure the effect on the process and/or product.
- Conduct analysis of customer complaints and establish defect trending
- Support the audit plan activity including product audits, process audits, supplier audits, and internal quality audits
- Determine process improvements for identifying new ideas and solutions in root cause analysis, corrective actions, and QA audits. Interface with all internal departments, auditors, and customers.
- 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.
- Responsible for being a communication liaison between the customer and manufacturing facility
- Establish validated test methods, molds, and assembly equipment.
- Lead Advanced Quality Planning process and develop product quality criteria during new product introduction.
- Work with Program Management, Manufacturing, Quality, and the customer to resolve issues and achieve timelines
- Drive continual improvement via Key Performance Indicators (KPIs)
- Serve as a subject matter expert to provide support during customer and regulatory inspections, reviews, and on-site meetings
- Prepare and complete Validation Protocols and Reports in support of product & process changes, as well as the new product introduction effort
The Experience You Will Bring
- Bachelor’s Degree in Engineering or a related field
- Experience and working knowledge of FDA Quality System Regulations, ISO 13485, and CFR 820
- Experience with equipment qualification and process validation
- Experience in a customer-facing role
What Will Put You Ahead
- SAP or other ERP system experience
- Experience with non-conformances, FMEA’s and CAPA’s
- Experience with manufacturing processes, injection molding, automated and manual assembly processes, statistical techniques, cleanroom function and controls
- Experience with Minitab
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.
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.
Equal Opportunity Employer, including disability and protected veteran status.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.
This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com
This role is not eligible for VISA sponsorship