Quality Engineering Lead - CAPA, Process Controls & NPD

Katalyst CRO; Cheyenne (WY); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies that meet medical device requirements, while serving as a Quality representative across development, manufacturing, and supplier interfaces. This role is based in Cheyenne, WY and involves leading cross-functional quality initiatives.

You will lead CAPA, conduct root cause analyses, drive post-market surveillance activities, and mentor technical staff, collaborating with contract

Qualifications

• BS degree in a related field; MS preferred for advanced roles.
• 5+ years of quality engineering experience; medical device background
• Experience owning CAPA and post-market surveillance activities
• Proven root cause analysis and problem-solving skills
• Ability to lead cross-functional teams and mentor staff

Responsibilities

• Lead quality initiatives across development and manufacturing to meet regulatory requirements.
• Drive CAPA programs, root cause analysis, and corrective actions.
• Oversee post-market surveillance and ongoing quality system improvements.
• Collaborate with contract manufacturers and internal design teams on quality changes.
• Mentor engineers and provide technical guidance on quality practices.

Skills

Quality engineering

CAPA

Root cause analysis

Post-market surveillance

Leadership

Independent work

Coordination with manufacturers

Design changes support

Education

BS in a relevant field

MS preferred

Job description

Katalyst CRO is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies that meet medical device requirements, while serving as a Quality representative across development, manufacturing, and supplier interfaces. This role is based in Cheyenne, WY and involves leading cross-functional quality initiatives.

You will lead CAPA, conduct root cause analyses, drive post-market surveillance activities, and mentor technical staff, collaborating with contract