QMS Manager

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Paid maternity/paternity leave

Tuition reimbursement

Long-term disability

Job summary

Excelitas Technologies is seeking a QMS Manager in Boulder, CO to oversee all Quality Management System functions, drive continuous improvement, and ensure compliance with ISO 9001, ISO 13485, ISO 14971, and FDA 21 CFR 820. The role leads manufacturing process improvements and NPI initiatives.

The ideal candidate has a BS in engineering or quality management and 5+ years in advanced manufacturing or related sectors, with ASQ or similar certifications preferred.

Qualifications

• Requires BS in Electrical/Industrial/Mechanical Engineering or Quality Management.
• 5+ years of Quality Management experience in Advanced Manufacturing, Bioscience, Semiconductor, Aerospace or Defense.
• Strong knowledge of ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820.

Responsibilities

• Oversee all Quality Management System functions including Document Control, Internal QMS Audits, Customer & Supplier Audits, RMA and Customer Complaints.
• Improve and optimize the QMS for effectiveness and standardized procedures globally.
• Lead cross-functional teams to drive quality and yield improvements.

Skills

Lean Enterprise

Six Sigma

Problem solving

MS Office Suite

Education

Bachelor of Science

Electrical Engineering

Industrial Engineering

Mechanical Engineering

Quality Management

Tools

MS Office Suite

Statistical methods

Job description

QMS Manager

Location: Boulder, CO, US, 80301

Job Function: Quality/CI

Job Country: United States

Job City: Boulder

Job Type: Regular Full Time

ENABLE your future through light.

Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors.

ENGAGE with us today and make your contribution to the future! Join the team that leading technology companies turn to for cutting-edge photonic innovation. At Excelitas Technologies you are how we EXCEL.

We are presently seeking aQuality Management System Manager that be responsible for continous improvement and maintenance of the site QMS and in the support of manufacutring process improvements.

Main responsibilities:

• Oversee all Quality Management System functions, including Document Control, Internal QMS Audits, Customer & Supplier Audits, Returned Material Authorizations, and Customer Complaints.
• Improve and optimize the Quality Management System (QMS) to ensure effectiveness and efficiency while ensuring the standardization of procedures within Excelitas globally
• Support quality improvement initiatives at the site to address the cost of poor-quality contributors
• Cultivate a culture of continuous improvement and operational excellence within the organization
• Provide cross-functional team leadership to drive quality and yield improvement initiatives
• Ensure that all manufacturing processes and finished products meet internal specifications, customer requirements, and regulatory compliance standards
• Plan, coordinate, and actively engage in new product introductions (NPI), product qualifications, design verifications, and risk assessments, which encompass process failure mode and effects analysis.
• Ensure adherence to ISO standards such as ISO 9001, ISO 13485, ISO 14971, and FDA 21 CFR 820 according to site accreditation requirements
• Address and resolve customer complaints through effective corrective and preventative actions
• Utilize statistical tools and root cause analysis methods such as SPC, Pareto Diagrams, Affinity Diagrams, Fault-Tree Analysis, Design of Experiments, Fish-Bone Analysis, to drive quality improvements, including training and guidance to site employees
• Assist in the maintenance and training of the site on ISO standards and regulations according to site accreditations
• Support and coordinate site Root Cause Investigations and Corrective and Preventative Actions (CAPA), including Supplier Corrective Actions (SCARS)
• Conduct on-going QMS effectiveness reviews, quality performance analysis, and reporting site opportunities for improvement
• Other duties as assigned

Requirements:

• Bachelor of Science degree required, BS in Electrical, Industrial, Mechanical Engineering, Quality Management, or related field.
• 5+ years of experience in Quality Management within Advanced Manufacturing, Bioscience, Semiconductor, Aerospace, or Defense Industry Environment
• Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820)

Preferred

• ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical Writing
• Understanding and familiarity with design history files, change management, manufacturing process control, material review boards, failure analysis, corrective/preventive actions, and verification testing per cGMP requirements, and FDA QSR / ISO 9001/ ISO13485/ ISO 14971
• Experience in NPI (New Product Introductions) process management and product quality planning
• Formal training in statistical techniques in a manufacturing environment with Six Sigma training and certification
• Knowledge and experience with continuous improvement techniques such as Lean Enterprise, Six Sigma, Kaizen, SPC, etc.
• Experience in Supplier Quality Management
• Excellent verbal and written skills, including proficiency in MS Office Suite of applications

Benefits start day 1: Medical, Dental, Vision, 401K, Holiday Pay, PAID Maternity/Paternity leave, Tuition Reimbursement, Long-term and Short-term disability.

Pay Range: $115,000 - $135,000 per year, depending on experience.

Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors.

ENGAGE with us today and make your contribution to the future! Join the team that leading technology companies turn to for cutting-edge photonic innovation.At Excelitas Technologies you are how we EXCEL.

Our facility in Boulder, Coloradohas key functions in Research and Development, Operations, Production, and other disciplines. This facility specializesin the manufacturing of ultra-precision optical components, optical thin film coatings and optical sub-assemblies for demanding applications in lasers, materials processing, instrumentation, life sciences, avionics, and defense.

This site offers capabilities that include substantial design and engineering resources, comprehensive optical fabrication and coating capabilities, advanced assembly technology and an extensive in-house metrology lab.

#LI-FM1 #LI-Onsite

This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR)

Visa sponsorship is not available for any position at Excelitas

Minorities/Females/Disability/Veteran/Gender Identity/Sexual Orientation

Excelitas is seeking leaders and innovators to join our global team!