Senior Quality Engineer - Medical Device QA Leader

Automatic Data Processing, Inc.; Westminster (CO); On-site; USD 100,000 - 120,000; Full time

Job summary

TriSalus Life Sciences seeks a Senior Quality Engineer to act as the technical authority across the product lifecycle, ensuring FDA/ISO compliance and leading cross-functional quality initiatives in Westminster, CO.

You will mentor engineers, drive quality system improvements, and own supplier quality, process validation, and audits to sustain regulatory and product quality standards. Expect strong collaboration with R&D and Operations on sterilization strategies and regulatory guidance.

Qualifications

• BS in Engineering, Science, Biomedical, or related field.
• CQA or Lead Assessor certification is preferred.
• CQE certification is a plus.
• ASQ CQE certification is advantageous.
• Passport required for travel as needed.

Responsibilities

• Own supplier quality management program enterprise-wide.
• Lead manufacturing quality and inspection plan development.
• Drive root cause analysis for complex defects.
• Lead IQ/OQ/PQ validation and Gage R&R efforts.
• Manage external standards documents and regulatory requirements.
• Lead internal audits and mentor junior engineers.
• Investigate NCRs and drive CAPA actions.
• Collaborate with R&D and Operations on sterilization strategies.

Skills

Quality leadership

Root cause analysis

FDA/ISO knowledge

Mentoring

Statistical methods

Auditing

Process validation

Gage R&R

Regulatory compliance

Education

BS in Engineering or related

CQA or Lead Assessor certification

CQE certification preferred

ASQ CQE

Tools

Minitab

Excel

PowerPoint

SharePoint

Outlook/Teams

Job description

TriSalus Life Sciences seeks a Senior Quality Engineer to act as the technical authority across the product lifecycle, ensuring FDA/ISO compliance and leading cross-functional quality initiatives in Westminster, CO.

You will mentor engineers, drive quality system improvements, and own supplier quality, process validation, and audits to sustain regulatory and product quality standards. Expect strong collaboration with R&D and Operations on sterilization strategies and regulatory guidance.