NPI Quality Engineer

Your Job

Phillips Medisize, a Molex company, is seeking a New Product Introduction Quality Engineer at our Costa Mesa, CA facility.

This position will be responsible for developing and maintaining quality plans for new and revised products in a manner consistent with corporate quality policy.

Our Team

Our Quality Engineers collaborate closely with production and engineering teams to support new product introduction, including the validation and qualification of new assembly and molding processes.

What You Will Do



* Develop quality plans for new products and product changes, including inspection methods, inspection equipment, and inspection frequency.


* Provide quality expertise in the development of Failure Mode and Effects Analyses (FMEAs), Control Plans, Qualification Plans, and other advanced quality planning activities.


* Perform statistical analysis to support qualification, process control, and continuous improvement for new and changed products and processes.


* Complete customer-required quality documentation supporting the acceptance of new products and product changes, and review supplier documentation for new and revised purchased components.


* Lead root cause and corrective action activities for new product quality issues and support systemic improvements to Advanced Quality Planning processes.


* Provide technical quality guidance to cross-functional teams and support customer-facing quality activities for new products.


* Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for processes and equipment while supporting applicable quality, Six Sigma, ISO, environmental, health, and safety management systems.

Who You Are (Basic Qualifications)



* Bachelor's degree in Engineering and/ or 3+ years of Quality Engineering experience


* Experience supporting new product introduction (NPI), including quality planning, process/product qualification, and cross-functional product launch activities


* Experience applying quality planning and risk-management tools such as FMEA, Control Plans, statistical process capability, and measurement system analysis

What Will Put You Ahead



* Experience in a regulated manufacturing environment


* Knowledge of metrology and Geometric Dimensioning and Tolerancing (GD&T)


* Experience with statistical quality tools, including process capability (Cpk) and Gage R&R


* Customer-facing quality experience


* Working knowledge of progressive molding and assembly processes


* Quality system and supplier auditing experience


* Gage and fixture design experience


* Certified Quality Engineer (CQE) certification

This role is not eligible for VISA sponsorship.

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.

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