Quality Engineer

KOCH INDUSTRIES INC • New Richmond, WI • 18h ago

JOB REQUIREMENTS: Your Job: Phillips Medisize, a Molex Company, is
seeking a contribution-motivated Quality Engineer to join our New
Richmond, Wisconsin location. 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. 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 Design FMEA,
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. 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, 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. At Koch companies, we are entrepreneurs.
This means we openly challenge... For full info follow application
link. Equal Opportunity Employer, including disability and protected
veteran status. *** APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/284EE26071864F12

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