Engineer, Supplier Quality
We are Phillips-Medisize, a Molex company. We are an end-to-end provider of innovation, development and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.
Our primary business focus is on complex, regulated drug delivery devices and connected health solutions.
Phillips-Medisize Costa Mesa LLC is looking for a Supplier Quality Engineer to join our Quality Engineering team. We are looking for someone that will improve supplier quality and support activities to improve outcomes in manufacturing.
What You Will Do In Your Role
- Implement systems and procedures that assure compliance with Quality Standards
- Coordinate new process techniques that improve overall job efficiencies
- Support NPI and sustaining QE for development and implementation of statistical incoming and in-process sampling/control plans
- Complete suppliers risk assessment and qualify suppliers
- Using the Statistical Process Control (SPC), Advanced Quality Process (AQP) tools and the Metrics, proactively identify and help implement improvement to the Supplier Quality and Supplier Quality Tools and Processes
- Promote the use of Statistical Process Control (SPC) and continuous improvement techniques at Suppliers to help them reduce variability and achieve process control
- Train Suppliers to effectively execute Supplier Corrective Actions Preventive Actions (SCAPA)
- Initiate and follow-up SCAPA in partnership with Manufacturing Engineering to ensure complete and effective root cause analysis and corrective action implementation
- Perform periodic audits of Supplier Quality Systems for the purpose of assuring continued Supplier conformance to the quality system requirements.
The Experience You Will Bring
- Understanding of the project development process, associated terminology, and quality system requirements.
- Independently determines and develops approach to solutions.
- Ability to effectively present information.
- Strong verbal and written communication, teamwork, and organizational skills.
- Ability to motivate and influence people to achieve customer satisfaction.
- Demonstrable track record of project accomplishment.
- Bachelor’s degree in an engineering field
- 3+ years’ minimum experience in Supplier Quality Engineering
- Experience in medical device industry
- Quality, ISO, or SPC certifications
- Knowledge of medical device manufacturing systems and ISO 13485 preferred.
- Strong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creation
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