Quality Management System Manager (Advanced Manufacturing)

TL;DR

Quality Management System Manager (Manufacturing): Overseeing all QMS functions including document control and audits with an accent on continuous improvement and regulatory compliance. Focus on optimizing quality systems, driving yield improvement, and ensuring adherence to ISO and FDA standards.

Location: Boulder, CO, US. Visa sponsorship is not available. Position subject to ITAR regulations.

Salary: $115,000 - $135,000 per year

Company

A global technology leader providing photonic innovation for biomedical, semiconductor, industrial, and aerospace sectors.

What you will do

• Oversee QMS functions including Document Control, Internal/External Audits, RMAs, and Customer Complaints.
• Optimize and standardize QMS procedures globally to ensure efficiency and effectiveness.
• Lead cross-functional teams to drive quality, yield improvements, and address cost of poor quality.
• Manage New Product Introductions (NPI), including design verifications and risk assessments (PFMEA).
• Ensure strict adherence to ISO 9001, ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Perform root cause analysis using tools like SPC, Pareto, and Fish-Bone to drive corrective actions (CAPA).

Requirements

• Bachelor's degree in Electrical, Industrial, Mechanical Engineering, Quality Management, or a related field.
• 5+ years of experience in Quality Management within Advanced Manufacturing, Bioscience, Semiconductor, Aerospace, or Defense.
• Strong knowledge of ISO 9001, ISO 13485, ISO 14971, IATF 16949, and FDA 21 CFR 820.
• Must be eligible to work in the US without sponsorship.
• Compliance with ITAR regulations is required.

Nice to have

• ASQ certified Quality Manager or ISO Lead Auditor certification.
• Six Sigma certification and formal training in statistical techniques.
• Experience with Lean Enterprise, Kaizen, and Supplier Quality Management.
• Proficiency in technical writing and MS Office Suite.

Culture & Benefits

• Comprehensive health package: Medical, Dental, and Vision starting day 1.
• Financial security via 401K and disability insurance.
• Family-friendly benefits including PAID Maternity/Paternity leave.
• Investment in growth through Tuition Reimbursement.
• Paid holidays and a culture of operational excellence.