Quality Engineer

Your Job

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Engineer to join our St.

Croix Meadows manufacturing facility in Hudson, WI.

You will create value by stewarding New Product Introductions (NPI) with your background in pharmaceutical 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 within 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 pharmaceutical regulatory requirements (FDA, GMP, ICH, etc.).


* Oversee proper handling, storage, and transportation of pharmaceutical drugs during NPI processes to maintain product integrity and quality.


* Collaborate with R&D, manufacturing, and supply chain teams to establish quality standards and processes for new products.


* Ensure compliance with regulations related to controlled substances, hazardous material handling, and cold chain logistics


* Develop and implement quality plans, risk assessments, and validation protocols for NPI projects.


* Conduct root cause analysis and drive corrective and preventive actions (CAPAs) for project-related quality issues.


* 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.


* 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.

Who You Are (Basic Qualifications)



* Bachelor's degree or higher in a scientific discipline


* 3+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry


* 3+ years of direct experience in drug manufacturing


* Highly competent working knowledge of ICH and relevant CFRs and other industry guidelines


* Proficiency in quality management tools, methodologies (e.g., risk assessment, root cause analysis, FMEA), and software systems

What Will Put You Ahead



* Proven experience in GxP audits, quality management systems, and CAPAs


* Strong analytical skills for data analysis and trend identification


* Competency in statistical tools and process validation


* Effective cross-functional collaborator wit...