Quality Engineer II

Quality Engineer II – Safeguard Medical

Location:

Huntersville, NC (Onsite, Full‑time)

Safeguard Medical is a global leader in emergency medical technology, dedicated to saving lives through innovative products and training solutions.

As a Quality Engineer II you will be the voice of Quality within a cross‑functional team, responsible for ensuring adherence to the Quality System and external standards across operational support functions. You will lead complex projects, perform root‑cause analysis, and champion statistical tools to drive continuous improvement.

• Execute quality engineering activities for operational support, including risk management, classification of quality characteristics, and design verification/validation.
• Perform root cause analysis and implement corrective and preventive actions, supporting CAPA/SCAR initiatives.
• Apply statistical tools (SPC, sample size determination, decision‑making) to analyze data and identify process improvements.
• Support clean‑room monitoring, environmental controls, and supplier quality issues.
• Collaborate closely with Quality Control, manufacturing, and warehouse teams to implement process improvements and maintain documentation.
• Assist with change management, including risk documentation, records, and supplier quality management.
• Develop and validate test methods, maintain traceability, perform Gage R&R studies, and ensure metrology compliance.
• Conduct internal and external audits, supplier audits, and assist with compliance to national and international standards.
• Define and apply product and process control methods, including control plans and work instructions.
• Contribute to corporate technical programs such as system improvement and remediation initiatives.

• Bachelor’s degree in a STEM discipline or equivalent experience.
• 3–6 years’ experience in the medical device or pharmaceutical field (preferred).
• Experience with risk identification, mitigation, and risk management.
• Knowledge of manufacturing processes, sterilization, and packaging validation (preferred).
• Proficiency in statistical analysis tools (Minitab, etc.).
• Experience in 3D modeling and drafting (preferred).
• Strong written and verbal communication skills, with demonstrated problem‑solving and organizational abilities.
• Capability to plan, execute, and deliver projects independently, while collaborating across functions.
• Excellent critical‑thinking skills, including DMAIC and structured root‑cause analysis.
• Ability to analyze data using statistical methods and apply risk‑based decision making.

• Positive, can‑do attitude and strong team player.
• Detail‑driven and reliable under pressure.
• Self‑directed with ownership and accountability.
• Collaborative leader who influences without authority.
• Effective communicator with medical professionals, sales, and cross‑functional teams.
• Strong organizational skills and ability to handle multiple initiatives.
• Understanding of change management, conflict resolution, and team dynamics.

• Competitive base salary with performance bonus.
• Generous time‑off allowance and retirement support.
• Comprehensive medical, dental, vision, and life insurance.
• Employee Assistance Program (EAP).
• Tuition reimbursement and referral programs.
• Opportunities for career growth in a purpose‑driven organization.

• Ownership – take charge and drive success.
• Initiative – act boldly and efficiently.
• Curiosity – ask why and innovate.
• Candor – speak openly and respectfully.
• Humility – lead selflessly for shared success.

Safeguard Medical is a proud Equal Employment Opportunity (EEO) and affirmative action employer. We maintain a merit‑based workplace that resists discrimination on the basis of race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other legally protected characteristics.

We seek to recruit, develop, and retain the most talented individuals from a diverse candidate pool.

To join our mission‑driven team, please submit your application through our career portal. We look forward to learning how your passion and expertise can help protect life worldwide.