Phillips Medisize · 6 hours ago
Quality Engineer
New Richmond, WI
Full-time
Onsite
Mid LevelPhillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Engineer to join their New Richmond, Wisconsin location. The role involves leading quality assurance activities for new product introductions in the medical device industry, ensuring compliance with regulatory requirements, and driving continuous improvement efforts to enhance product quality.
Health CareHealth DiagnosticsManufacturingOutsourcing
No H1B
Responsibilities
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
Qualification
Required
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
Benefits
Medical
Dental
Vision
Flexible spending and health savings accounts
Life insurance
ADD
Disability
Retirement
Paid vacation/time off
Educational assistance
Infertility assistance
Paid parental leave
Adoption assistance
Company
Phillips Medisize
As a contract development and manufacturing organization (CDMO), the world’s leading pharmaceutical, medtech and in vitro diagnostic companies trust us to help them design and manufacture their products.
Founded in 1964
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2016-08-17Acquired
Leadership Team
Arnie DeWitt
CIO
Robbie Adams, MBA
Sr Analyst-Finance Business Partner
Recent News
2025-07-04
Company data provided by crunchbase