Quality Management System (QMS) Manager

About the role

Excelitas Technologies is seeking a senior Quality Management System (QMS) Manager to lead continuous improvement and maintain the site QMS for its advanced photonic manufacturing operations in Boulder, CO.

Key responsibilities

• Oversee all QMS functions including document control, internal and external audits, returned material authorizations, and customer complaints.
• Drive quality and yield improvement initiatives, support new product introductions, and ensure compliance with ISO 9001, ISO 13485, ISO 14971 and FDA 21 CFR 820.
• Lead cross‑functional teams in root‑cause investigations, CAPA, and supplier corrective actions.
• Conduct effectiveness reviews, performance analysis and report improvement opportunities.

Required profile

• Bachelor’s degree in Engineering, Quality Management or related field.
• 5+ years of quality management experience in advanced manufacturing (e.g., bioscience, semiconductor, aerospace, defense).
• Strong knowledge of ISO 9001, ISO 13485, ISO 14971, IATF 16949 and FDA QSR.
• ASQ Certified Quality Manager or ISO Lead Auditor preferred.

Required skills

• Statistical tools and root‑cause analysis methods (SPC, Pareto, Fault‑Tree, DOE, Fish‑Bone, Affinity diagrams).
• Continuous‑improvement methodologies (Lean, Six Sigma, Kaizen).
• Experience with NPI process management, CAPA, and supplier quality management.
• Proficiency with MS Office Suite.

What we offer

• Medical, dental, vision, 401(k), holiday pay, paid parental leave.
• Tuition reimbursement, long‑term and short‑term disability.
• Competitive salary range $115,000‑$135,000 per year.