Client Business Driver
Our client is a medical device company that specializes in emergency medical technology to provide their customers with lifesaving tools and skills.
The Work
We are seeking a Quality Engineer II to serve as a key member of a cross-functional team with primary responsibility for quality management in Operational support. This role ensures compliance with all applicable elements of the Quality System and external regulatory standards. Acting as the voice of Quality, the Quality Engineer applies best practices—including team-based problem-solving, statistical methods, and robust root cause analysis—and champions the use of these tools across the organization.
The Quality Engineer will lead and execute projects of varying complexity, requiring minimal oversight from management. Success in this role depends on the ability to collaborate effectively with all levels of the organization—from operators and inspectors to senior leadership—while driving continuous improvement and strengthening a culture of quality
Key Responsibilities
- Operational Quality Support: 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.
- Problem Solving & CAPA SystemsPerform 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.
- Statistical & Analytical Tools: 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.
Supplier & Change Management
- 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.
Audits & Compliance
- 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.
Test Methods & Controls
- 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.
Qualifications
- 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 Skills: 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.
Expected Commitment
This will be a full-time permanent role. Onsite in Charlotte, NC.
