QMS Manager (Manufacturing)

TL;DR

QMS Manager (Manufacturing): Overseeing and optimizing the site Quality Management System and supporting manufacturing process improvements with an accent on ISO standards compliance and operational excellence. Focus on driving quality and yield improvement initiatives and resolving customer complaints through root cause analysis.

Location: Boulder, CO, US. Visa sponsorship is not available. This position is subject to International Traffic in Arms Regulations (ITAR).

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 all QMS functions, including Document Control, Internal QMS Audits, Customer & Supplier Audits, and Customer Complaints.
• Optimize the Quality Management System to ensure global standardization, effectiveness, and efficiency.
• Lead cross-functional teams to drive quality and yield improvement initiatives and address the cost of poor quality.
• Ensure strict adherence to ISO 9001, ISO 13485, ISO 14971, and FDA 21 CFR 820 standards.
• Coordinate new product introductions (NPI), product qualifications, design verifications, and risk assessments.
• Manage Root Cause Investigations and Corrective and Preventative Actions (CAPA), including Supplier Corrective Actions (SCARS).

Requirements

• Bachelor of Science 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 environments.
• Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820).
• Must be authorized to work in the US; visa sponsorship is not available.
• Ability to handle information subject to International Traffic in Arms Regulations (ITAR).

Nice to have

• ASQ certified Quality Manager or ISO Lead Auditor Certification.
• Formal training and certification in Six Sigma and continuous improvement techniques (Lean Enterprise, Kaizen, SPC).
• Experience in New Product Introductions (NPI) process management and Supplier Quality Management.
• Proficiency in technical writing and MS Office Suite.

Culture & Benefits

• Comprehensive health benefits from day 1: Medical, Dental, and Vision.
• Financial security with 401K, Long-term, and Short-term disability insurance.
• Paid Maternity/Paternity leave and Holiday Pay.
• Tuition Reimbursement for ongoing professional development.