Quality Engineer

Your Job

Our Global Technical Services team is seeking a contribution-motivated Quality Engineer to support operations in our Hudson, WI site and other Wisconsin locations. You will create value by stewarding New Product Introductions (NPI) with your background in Medical Device Quality Assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.

Our Team

Phillips Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. We work collaboratively with our Global Quality Organization to deliver compliant and effective solutions to our customers.

What You Will Do

* Lead quality assurance activities for new product introduction (NPI) projects to ensure compliance with regulatory requirements (FDA, GMP, ISO 13485, etc.)

* Develop and maintain quality plans for new medical device product introductions

* Perform audits and inspections of NPI processes to ensure adherence to internal and external quality standards

* Manage and oversee quality documentation, including specifications, validation reports, and product dossiers

* Manage SAP activities such as generating and maintaining Quality Notifications, Document Control, Batch Records, Calibrations, and RMA/complaint systems

* Work with project teams and Validation leads to define the validation strategy

* Draft MVPs, equipment qualification, protocol/test case, deviations and summary report documentation for project wrap up

* Support regulatory submissions by compiling and reviewing quality-related documentation

* Monitor product performance during initial production runs to identify opportunities for improvement

* Facilitate training and knowledge sharing across teams regarding quality expectations and best practices

* Stay informed of industry trends and regulatory updates to ensure compliance and competitiveness

* Lead risk management activities including Process FMEA and Control Plans

* Collaborate with suppliers on quality requirements and audits to ensure component and material quality

* Facilitate root cause investigations and corrective actions for quality issues during product launch

* Conduct quality reviews and ensure alignment with internal standards and external regulatory bodies

* Assist with documentation and audit readiness for FDA inspections and ISO 13485 certification

* Drive continuous improvement efforts to enhance product quality and manufacturing processes

* Role requires intermittent travel to support engineering efforts at other Phillips Medisize sites or vendor sites

Who You Are (Basic Qualifications)

* Bachelor's degree in engineering, Quality, Life Sciences, or related field

* Experience with FDA QSR, ISO 13485, and medical device regulatory environment

* Strong knowledge of quality tools such as SPC, Process Capability, RCA, FMEA, 8D, CAPA

* Excellent problem-solving skills and ability to work cross-functionally

* Experience with product validation, verification, and risk management in medical devices

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

This role is not eligible for VISA sponsorship.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location.

If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Hiring Philosophy

All Koch companies value diversity of…