Quality Systems Engineer

Oxxius; Williston (VT); On-site; USD 85,000 - 110,000; Full time

Job summary

Oxxius, Inc., an optical engineering firm in the Burlington area, is seeking a Quality Systems Engineer to drive the QMS and continuous improvement across engineering and production. You will lead customer quality activities, supplier qualifications, and QA initiatives while maintaining ISO 9001 compliance and supporting audits.

The role requires 3–5 years of related experience, a BS in engineering or related field, and strong analytical, leadership, and communication skills to work across

Qualifications

• 3-5 years relevant work experience.
• BS degree in Engineering or relevant field.
• Experience with complex assembly production.
• Knowledge of ISO standards and quality processes.
• Familiarity with business processes (Sales, quoting, development, service, inventory).
• Strong analytical/problem solving skills and statistical thinking.
• Experience training others in processes and procedures.
• Ability to communicate professionally with peers, customers and suppliers.
• Ability to lead or participate in multidisciplinary teams.
• Self-directed and detail-oriented with multitasking ability.
• Authorized to work in the United States.

Responsibilities

• Serve as focal point for customer quality activities including RMAs and audits.
• Manage supplier qualification evaluations and corrective actions.
• Support incoming, in-line, and outgoing quality.
• Lead or contribute to quality processes like change management and FMEA.
• Ensure ISO 9001 compliance through audits and surveillance.
• Model and drive internal quality audit programs and external audits.
• Lead process improvement initiatives and training on QMS.
• Maintain and communicate QMS improvements and responsibilities.
• Collaborate with production, engineering, suppliers, and customers.

Skills

Analytical skills

Problem solving

Multitasking

Communication

Leadership

Self-directed

Detail oriented

Education

BS in Engineering or related field

Tools

SolidWorks

PDM/PLM

BOM management

Job description

Oxxius, Inc. is an award-winning optical engineering design and manufacturing firm located in the Burlington, Vermont area. The company specializes in advanced illumination and imaging systems for life-science, biomedical, and industrial research. Oxxius Inc’s expertise in laser and imaging system design is recognized by scientists and engineers worldwide.

Overview

The Quality Systems Engineer is the focal point for Oxxius’ Quality Management System and continuous improvement. This role works across the organization and closely with Engineering and Production to ensure customer quality issues are addressed. As part of the QMS, the Quality Systems Engineer will provide leadership on continuous improvement projects focused on manufacturing operations and business processes.

Key Responsibilities

• Focal point for customer quality activities, which include customer returned materials (RMA) and corrective action requests, customer quality assurance agreements, and coordinating and leading customer audit requests.
• Manage supplier qualification activities, evaluations, and supplier corrective actions.
• Support incoming inspection, in-line product quality and out-going quality.
• Integral contributor to or leading of one or more quality processes like change management, non-conformance, quality review board, structured problem solving, FMEA
• Ensure ISO 9001 compliance as demonstrated by successful ISO re-certification and surveillance audits.
• Manage and conduct internal quality audit processes and drive external audit processes
• Provide leadership and guidance of process improvement projects in support of quality initiatives.
• Drive and perform quality management system maintenance, improvement, communication, and training.
• Demonstrate leadership and follow through on task responsibilities and projects, adaptability, collaboration across the organization, and high level of organizational and project management skills.
• Self-directed, highly motivated, and reliable.
• Must have excellent organization skills and a high attention to detail.
• Ability to organize and manage multiple priorities (effective multitasking skills).
• Clear, effective, and professional communication skills.
• Ability to analyze and resolve problems.
• Ability to work effectively with all individuals/groups within the organization.
• Ability to work independently but not afraid to ask questions.
• Combination of office and manufacturing floor environments.
• Regular interaction with production staff, engineering teams, suppliers, and customers.
• Participation in operational meetings, production reviews, and quality audits.

Required Qualifications/Experience

• 3-5 years relevant work experience
• BS degree in Engineering or relevant Business degree, or equivalent combination of education and/or experience
• Experience with complex assembly production
• Demonstrated knowledge and leadership experience of quality management processes, process documentation, and ISO standards
• Familiarity with standard business processes and business process reengineering: Sales, quoting, product development, customer service, inventory and order management, shipping, procurement, quality assurance
• Strong analytical/problem solving skills and ability to use statistical tools and techniques
• Demonstrable experience training others in process and procedures
• Ability to communicate effectively and professionally with co-workers, customers, and suppliers
• Demonstrated ability to lead and be part of multidisciplinary teams
• Self-directed and detail-oriented with the ability to multitask
• Must be authorized to work in the United States

Preferred Qualifications/Experience

• 5+ years of experience with complex opto-mechanical products and production/assembly
• Mechanical Engineering background/experience
• Experience with 3D CAD programs (SolidWorks)
• Experience with Product Data Management (PDM) and/or Product Lifecycle Management (PLM) software
• Experience with BOM management and engineering change orders (ECOs)

Physical Requirements

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this role.

• Ability to work in both office and manufacturing environments
• Ability to stand, walk, and move throughout the production floor as needed
• Occasional lifting of materials or equipment consistent with manufacturing environments