Confidential · 6 hours ago
Quality Engineer
Charlotte, NC
Full-time
Onsite
Mid, Senior Level
$87K/yr - $87K/yr
3+ years expConfidential is a medical device company specializing in emergency medical technology. They are seeking a Quality Engineer II to manage quality compliance, collaborate with various teams, and drive continuous improvement initiatives.
Staffing & Recruiting
Hiring Manager
Sayyad Kamarali
Responsibilities
Execute quality engineering activities in support of operations, including risk management documentation, classification of quality characteristics, review of technical drawings/specifications, design verification/validation, and process validation activities
Support cleanroom monitoring and environmental control activities in collaboration with manufacturing and quality control teams
Partner with Quality Control, Manufacturing, and Warehouse personnel to implement process improvements, ensure adequate resources, and maintain compliance with the Quality Management System
Perform robust root cause analysis of identified issues and recommend appropriate corrective and preventive actions
Support NC, Complaints, CAPA, and SCAR processes within the QE team to drive effective resolution
Lead supplier issue investigations, implement control measures, and ensure timely resolution
Apply statistical methods to collect, summarize, and interpret data; determine sample sizes; identify relationships between variables; and make data-driven decisions
Support the use of Statistical Process Control (SPC) and sampling plans (variable, attribute, zero-defect) with an understanding of producer/consumer risk, AQL, LTPD, AOQ, and AOQL
Conduct measurement system analyses such as Gage R&R and apply metrology techniques, including calibration, traceability, and error analysis
Support supplier management activities including selection, qualification, certification, and performance improvement
Provide technical support for process improvements, supplier changes, and design changes, ensuring risk management documentation and change control processes are comprehensive and compliant
Support incoming inspection processes and documentation to maintain supplier quality standards
Ensure compliance with internal, national, and international requirements and standards
Participate in internal, external, and supplier audits (both virtual and in-person)
Contribute to corporate quality initiatives, including system remediation, harmonization, and continuous improvement programs
Develop and validate test methods with appropriate oversight
Define, implement, and monitor product and process controls such as control plans, critical control points, and validated work instructions
Qualification
Required
Bachelor's degree in Quality Engineering, Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related STEM discipline, or equivalent experience required
3-6 years' experience in the medical device industry
Experience in risk identification, mitigation, and risk management
Proven track record of executing multiple projects / initiatives simultaneously, exhibiting appropriate prioritization of tasks and completing them with a sense of urgency
Preferred
Leadership experience
Experience with manufacturing processes and related documentation preferred
Experience with sterilization and packaging validation activities preferred
Minitab experience preferred
Experience in 3D modeling and drafting is preferred
Company
Confidential
Centralizing All Types Of Next Opportunities For You In One Place.
Vancouver, US
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase