Phillips-Medisize is seeking a motivated and self-driven 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. This role will identify, analyze, and support problem-solving activities and demonstrate proficiency with statistical methods, sampling, and design of experiments. The successful candidate will be an energetic self-starter and team player with strong written & oral communication skills as well as strong problem-solving skills.
What You Will Do In Your Role
- Lead the process that monitors manufacturing improvements to measure the effect on the process and/or product
- Assist the Quality Manager in establishing, implementing, and maintaining the quality system
- Evaluate and assess risks of nonconformities
- Conduct analysis of customer complaints and establish defect trending
- Facilitate and monitor CAPA process
- Support the audit plan activity including product audits, process audits, supplier audits, and internal quality audits
- Support the creation and maintenance of company quality documentation such as quality manuals, quality procedures, etc.
- Facilitate the adoption of quality concepts and techniques and possess the knowledge and ability to develop and administer management information systems to audit quality systems for deficiency identification and correction
- 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.
- Support supplier quality activities
The Experience You Will Bring
- Bachelor’s degree in Engineering
- Experience in a customer-facing role, specifically addressing quality-related customer complaints
What Will Put You Ahead
- Experience and working knowledge of FDA Quality System Regulations and ISO 13485
- Experience with non-conformances, FMEA’s and CAPA’s
- Experience with SAP
- Experience with supplier quality management
Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device, and specialty commercial markets.
Salary and Benefits Commensurate with Experience.
Equal Opportunity Employer.
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/doc/Everify.pdf