Our client, a Medical Devices/Healthcare company, is looking for a Quality Process Engineer II for their Sandy, UT location.
Responsibilities:
The Quality Process Engineer II will provide quality engineering support for manufacturing and quality system activities, with a focus on receiving/incoming inspections, nonconforming material documentation, in-process and final quality inspections, and CAPA support. This individual will also assist with the administration and maintenance of calibration and preventive maintenance quality programs to help ensure compliance with internal procedures and applicable regulatory requirements.
Conduct receiving and incoming inspections of materials, components, and products to verify conformance to specifications and quality requirements.
Perform and support in-process and final quality inspections as needed.
Initiate, document, and manage Nonconformance Reports (NCRs) for materials, components, and processes that do not meet requirements.
Support investigation, documentation, and follow-up activities related to Corrective and Preventive Actions (CAPA).
Assist in root cause investigations and help track implementation and effectiveness of corrective actions.
Review inspection results and quality records for completeness, accuracy, and compliance.
Support maintenance of the calibration program, including tracking due dates, coordinating calibrations, and maintaining related records.
Support maintenance of the preventive maintenance program and associated quality documentation.
Collaborate with cross-functional teams including Operations, Manufacturing, Supply Chain, and Quality Assurance to resolve quality issues.
Help ensure quality records are maintained in accordance with internal procedures and regulatory expectations.
Participate in audits, inspection readiness activities, and continuous improvement efforts as assigned.
Identify and escalate quality risks or trends to management.
Requirements:
Bachelor's Degree and 1 years of relevant experience, or Associate's Degree and 3 years of relevant experience, or High School Diploma or Equivalent and 5 years of relevant experience
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
Calibrationunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Documentationunmatched
Health Planunmatched
Healthcareunmatched
High School Diplomaunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Medical Equipmentunmatched
Preventative Maintenanceunmatched
Problem Solving Skillsunmatched
Process Engineeringunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Receiving Inspectionunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Root Cause Analysisunmatched
Supply Chainunmatched
Support Documentationunmatched
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