Senior Quality Engineer - MedTech CAPA & Compliance Lead

Talently; Boulder (CO); On-site; USD 110,000 - 140,000; Full time

Job summary

Talently in Boulder, CO is seeking a Senior Quality Engineer to strengthen quality systems for Class II/III medical devices. You will drive investigations, CAPA, design control, and change control while ensuring ISO 13485 and FDA compliance.

Join a fast-growing manufacturing environment that emphasizes regulatory excellence, lean initiatives, supplier quality, and cross-functional collaboration. Strong communication and mentoring skills are valued.

Qualifications

• Experience leading quality investigations and CAPA programs.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with design control, change control, and DHF updates.
• Proficient in risk management, statistics, and process validation.
• Hands-on supplier quality management and internal audits.
• Experience applying Lean manufacturing to improve quality.

Responsibilities

• Lead quality investigations, root cause analyses, and CAPA activities.
• Develop and maintain quality systems ensuring regulatory compliance.
• Collaborate with cross-functional teams on product development and manufacturing.
• Lead design control and change control efforts with DHF updates.
• Partner with operations on lean initiatives to improve quality and efficiency.
• Audit internal processes and interface with external auditors as needed.

Skills

ISO 13485:2016 & FDA 21 CFR Part 820"

Quality investigations, root cause &?

Design control & change control

Risk management, statistics & process

Supplier quality management & internal

Lean manufacturing

Mentorship & communication

Tools

Minitab

MS Excel

PLM systems

Job description

Talently in Boulder, CO is seeking a Senior Quality Engineer to strengthen quality systems for Class II/III medical devices. You will drive investigations, CAPA, design control, and change control while ensuring ISO 13485 and FDA compliance.

Join a fast-growing manufacturing environment that emphasizes regulatory excellence, lean initiatives, supplier quality, and cross-functional collaboration. Strong communication and mentoring skills are valued.