Phillips Medisize
Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin. We have opportunities available at our New Richmond, Menomonie, and Hudson facilities. This role will support, organize, and coordinate activities of the quality function with the goal of providing products/services that meet customer expectations. Devise and implement continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained.
What You Will Do
Ensure compliance with FDA 21 CFR 820 210:211, ISO 13485, and ISO 14971.
Review specifications and ensure adherence to material and process requirements.
Oversee validation and verification of manufacturing processes and equipment.
Manage documentation for change management and non-conformance reports.
Lead investigations and root cause analysis of non-conformances.
Author tech reports, CAPAs, compliant investigations, and validations.
Work with suppliers to meet quality requirements.
Support customer complaint management.
Troubleshoot manufacturing and field issues.
Analyze quality data and trends; identify improvement areas.
Champion continuous improvement initiatives.
Mentor junior quality engineers.
Collaborate with cross-functional teams.
Who You Are (Basic Qualifications)
Bachelor’s degree or equivalent experience
Minimum of 4 years of quality-related experience in a medical manufacturing environment
Experience working in a regulated environment
Knowledge of automated assembly and test procedures
Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485
Experience working with an ERP system (SAP)
Strong data analysis skills
Strong technical writing and problem-solving skills
Experience in packaging, serialization, sterilization, and complaint handling
Experience with updating the test procedures in testing equipment
What Will Put You Ahead
Experience in supplier quality management
Pharmaceutical experience
Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following information for additional information: E-Verify.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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What You Will Do
Ensure compliance with FDA 21 CFR 820 210:211, ISO 13485, and ISO 14971.
Review specifications and ensure adherence to material and process requirements.
Oversee validation and verification of manufacturing processes and equipment.
Manage documentation for change management and non-conformance reports.
Lead investigations and root cause analysis of non-conformances.
Author tech reports, CAPAs, compliant investigations, and validations.
Work with suppliers to meet quality requirements.
Support customer complaint management.
Troubleshoot manufacturing and field issues.
Analyze quality data and trends; identify improvement areas.
Champion continuous improvement initiatives.
Mentor junior quality engineers.
Collaborate with cross-functional teams.
Who You Are (Basic Qualifications)
Bachelor’s degree or equivalent experience
Minimum of 4 years of quality-related experience in a medical manufacturing environment
Experience working in a regulated environment
Knowledge of automated assembly and test procedures
Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485
Experience working with an ERP system (SAP)
Strong data analysis skills
Strong technical writing and problem-solving skills
Experience in packaging, serialization, sterilization, and complaint handling
Experience with updating the test procedures in testing equipment
What Will Put You Ahead
Experience in supplier quality management
Pharmaceutical experience
Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following information for additional information: E-Verify.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr