QMS Manager

QMS Manager

Location:

Boulder, CO, US, 80301

Job Function:
Quality/CI

Job Country:
United States

Job City:
Boulder

Job Type: Regular Full Time

We are presently seeking a Quality Management System Manager that will be responsible for continuous improvement and maintenance of the site QMS and support manufacturing process improvements.

• 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.

• 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).

• 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/ ISO
  13485/ 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.

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.