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