Quality Validation Engineer

Your Job

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.

Our Global Technical Services Team is seeking a Quality Engineer to support operations in to support our Costa Mesa, CA facility.

Our Team

This role will manage, organize, and coordinate the Quality activities with the goal of maximizing company profitability by providing products/services that meet customer expectations at the lowest cost.

Support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.

What You Will Do



* Lead AQP process, develop product quality criteria and execute associated deliverables during new product introduction.


* Establish Bill of Materials and control prints, drawings, and product specifications.


* Establish Supplier Controls and Purchase Part Approval Process deliverables.


* Establish validated test methods, molds, and assembly equipment.


* Establish drug and serialization deliverables.


* Establish quality system deliverables inclusive of quality events, deviations, MRBs corrections, CAPAs, Batch Records, and Certificates of Compliance.


* Initiate and manage customer/internal corrective actions using data based, structured, problem-solving methodology.


* Acknowledgment and understanding of all customers General Quality Agreements, General Quality Requirements, and standards, as set by each customer


* Travel to other Phillips-Medisize and vendor sites (up to 40%)


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


* Implement systems and procedures that assure compliance with Quality Standards


* Development and implementation of statistical incoming and in-process sampling/control plans

Who You Are (Basic Qualifications)



* Bachelor's Degree from an accredited college or university or 4 + years of direct Quality experience


* 1-year minimum experience working in a regulated manufacturing environment, medical manufacturing preferred

What Will Put You Ahead



* Strong organizational, and problem-solving skills and an understanding of the project development process, associated terminology, and quality system requirements


* Excellent communication skills and the ability to effectively present information and respond to questions from group of managers, sales, and customers


* Ability to identify problems, and develop and implement actions to resolve them


* Ability to motivate and influence people to achieve customer satisfaction


* Experience in the medical and/or pharmaceutical manufacturing industry


* Experience analyzing statistical data


* Experience working with SAP

For this role, we anticipate paying $85,000 - $105,000 per year.

This role is eligible for variable pay, issued as a monetary bonus or in another form.

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