QMS Manager - Quality & Compliance Leader

Excelitas Technologies Corp.; Boulder (CO); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

Holiday Pay

Paid Maternity/Paternity leave

Tuition Reimbursement

Long-term disability

Short-term disability

Job summary

Excelitas Technologies Corp. in Boulder, CO, is seeking a Quality Management System Manager to lead the site's QMS, drive continuous improvement, and support manufacturing process enhancements.

The role requires a BS in a related field and 5+ years in Quality Management within advanced manufacturing, bioscience, or defense sectors, with strong ISO and FDA knowledge. On-site role with comprehensive benefits.

Qualifications

• Bachelor of Science degree in a related field (Engineering or Quality Management).
• 5+ years of quality management experience in Advanced Manufacturing or related sectors.
• Strong knowledge of ISO 9001, ISO 13485, ISO 14971, IATF 16949 and FDA 21 CFR 820 requirements.

Responsibilities

• Oversee all QMS functions including document control and audits.
• Improve and optimize the QMS to standardize procedures across Excelitas globally.
• Lead quality and yield improvement initiatives with cross-functional teams.
• Ensure manufacturing processes and finished products meet specifications and regulatory standards.
• Coordinate NPI, product qualifications, design verifications, and risk assessments.

Skills

Quality management

Internal audits

Root cause analysis

SPC

CAPA

Statistical tools

Education

BS in Electrical, Industrial, Mechanical Engineering or Quality Management

Tools

MS Office Suite

Job description

Excelitas Technologies Corp. in Boulder, CO, is seeking a Quality Management System Manager to lead the site's QMS, drive continuous improvement, and support manufacturing process enhancements.

The role requires a BS in a related field and 5+ years in Quality Management within advanced manufacturing, bioscience, or defense sectors, with strong ISO and FDA knowledge. On-site role with comprehensive benefits.