Senior Quality Engineer — Med Device, CAPA & RCA Leader

Creative Solutions Services, LLC; Laramie (WY); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior Quality Engineering leader to advance the quality systems for medical devices, including CAPA, post-market surveillance, and design changes coordination with contract manufacturers.

You will mentor cross-functional teams, drive root-cause analysis, and implement robust process controls to meet regulatory requirements and customer expectations across hepatic artery infusion pump products and accessories.

Qualifications

• Minimum 5 years of experience with a BS; 3–4 years with an MS.
• Medical device experience is required.
• Experience owning CAPA and performing root cause analysis.
• Coordination with contract manufacturers and cross-functional teams.
• Knowledge of post-market surveillance and regulatory requirements.

Responsibilities

• Provides leadership on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical personnel.
• Proactively investigates and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance in identifying and resolving quality issues.
• Identifies and implements effective process control systems to support development, qualification, and manufacturing.

Skills

Quality leadership

CAPA management

Root cause analysis

Regulatory compliance

Medical device experience

Education

BS in Engineering

MS in Engineering

Tools

CAPA software

QMS software

Job description

Creative Solutions Services, LLC is seeking a senior Quality Engineering leader to advance the quality systems for medical devices, including CAPA, post-market surveillance, and design changes coordination with contract manufacturers.

You will mentor cross-functional teams, drive root-cause analysis, and implement robust process controls to meet regulatory requirements and customer expectations across hepatic artery infusion pump products and accessories.