Quality Engineer – Medical Devices, ISO 13485

Cqmedical; Pennsylvania; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health coverage starting Day One

Free life insurance

Disability insurance

401(k) with matching

Generous PTO and holidays

Job summary

Cqmedical is seeking a Quality Engineer to drive quality across manufacturing, engineering, and supply chain. You will lead investigations, perform root-cause analyses, and implement corrective actions to reduce defects and improve process capability.

The role collaborates with cross-functional teams to ensure regulatory and quality system compliance while supporting audit activities and continuous improvement.

Qualifications

• Bachelor's degree in a technical discipline and 3+ years in a quality-related role.
• Experience in medical devices and ISO 13485 environment preferred.
• CQE or equivalent certification preferred.

Responsibilities

• Lead investigations of manufacturing nonconformances and product quality issues.
• Develop and implement corrective actions within areas of responsibility.
• Support MRB activities and disposition decisions.
• Participate in product/process risk assessments throughout the lifecycle.
• Support validation protocols and verification activities.
• Maintain quality records and support internal/external audits.
• Develop and maintain inspection strategies and quality controls.

Skills

Quality engineering

Risk management

Statistical analysis

Process validation

Root cause analysis

Inspection strategies

Cross-functional leadership

Data-driven decisions

Communication

Education

Bachelor's degree in engineering/quality/manufacturing

ASQ CQE or equivalent

Tools

Statistical analysis software

Minitab (or equivalent)

Job description

Cqmedical is seeking a Quality Engineer to drive quality across manufacturing, engineering, and supply chain. You will lead investigations, perform root-cause analyses, and implement corrective actions to reduce defects and improve process capability.

The role collaborates with cross-functional teams to ensure regulatory and quality system compliance while supporting audit activities and continuous improvement.