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Phillips Medisize · 8 hours ago

Quality Engineer

Maumelle, AR

Full-time

Onsite

Mid Level

4+ years exp

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. The Quality Engineer will support manufacturing processes by leading quality improvements, monitoring production adherence to standards, and facilitating communication between departments.

Health CareHealth DiagnosticsManufacturingOutsourcing

No H1B

Responsibilities

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

Facilitate communication between engineering, manufacturing, and quality functions

Responsible for being a communication liaison between the customer and manufacturing facility

Qualification

Quality toolsRoot cause analysisCorrectivePreventive ActionERP system (SAP)Medical Manufacturing EnvironmentAuditing experienceSTEM DegreeCommunication skills

Required

STEM Degree and/ or 4+ years of quality experience in a manufacturing environment

Experience with root cause analysis (RCA) and Corrective and Preventive Action (CAPA)

Legal authorization to work permanently in the United States for any employer without requiring a VISA transfer or VISA sponsorship

Preferred

Auditing experience

One year of quality experience

Experience working with an ERP system (SAP)

Experience working in a Medical Manufacturing Environment (ISO 13485:2016, CFR Part 820)

Benefits

Medical

Dental

Vision

Flexible spending and health savings accounts

Life insurance

ADD

Disability

Retirement

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Company

Phillips Medisize

As a contract development and manufacturing organization (CDMO), the world’s leading pharmaceutical, medtech and in vitro diagnostic companies trust us to help them design and manufacture their products.

Founded in 1964

Hudson, Wisconsin, USA

5001-10000 employees