Senior Quality Engineer

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

Skills: ISO, FDA

About the Medical Devices Industry / The Opportunity:

Join a leading organization in the medical devices sector dedicated to improving patient lives through innovative, high‑quality products. Our client operates a fast‑growing manufacturing environment that emphasizes regulatory compliance, continuous improvement, and cross‑functional collaboration. The Senior Quality Engineer role offers the chance to shape quality systems, lead investigations, and drive excellence across Class II and Class III device production.

Responsibilities:

• Lead and conduct quality investigations, root cause analyses, and CAPA activities to resolve product and process issues.
• Develop, implement, and maintain quality systems and procedures ensuring ISO 13485 and FDA 21 CFR Part 820 compliance.
• Participate in cross‑functional teams to embed quality into product development, design control, and manufacturing processes.
• Lead design control and change control efforts, including updates to design history files and change documentation.
• Collaborate with operations on lean initiatives to enhance manufacturing efficiency and product quality.
• Create and deliver operator training programs and qualification assessments.
• Conduct internal audits and interface with FDA and ISO auditors during inspections.
• Monitor supplier performance, develop quality metrics, and drive continuous improvement projects.

Must-Have Skills:

• Strong knowledge of ISO 13485:2016 and FDA 21 CFR Part 820 regulations.
• Extensive experience with quality investigations, root cause analysis, and CAPA management.
• Proficiency in design control and change control processes for medical devices.
• Expertise in risk management, statistical analysis, and process validation.
• Hands‑on experience with supplier quality management and internal auditing.
• Ability to apply Lean Manufacturing principles to improve quality and efficiency.
• Excellent communication, problem‑solving, and mentorship skills.

Nice-to-Have Skills:

• Familiarity with Six Sigma methodologies and tools.
• Experience with statistical software (e.g., Minitab) for data analysis.
• Knowledge of medical device software validation requirements.
• Proficiency in MS Office suite, especially Excel for data reporting.
• Exposure to product lifecycle management (PLM) systems.