Job Description

Benefits:

U.S.-based employees have access to medical, dental, and vision insurance, a 401(k) plan and company contribution, short-term and long-term disability coverage, basic life insurance, and wellbeing benefits, among others. U.S.-based employees also receive, per calendar year, up to 6 scheduled paid holidays. Additionally, eligible hourly/non-exempt and exempt employees accrue up to 112 hours of PTO based on years of service and may annually take up to 8 hours of paid volunteer time.  Additional paid sick leave is also provided if required by state or local law.  

Summary of Position:

The Quality Engineer supports the implementation and sustainment of Denali’s Quality Management System and PLM processes. This role works closely with engineering, operations, and service delivery teams to monitor performance, drive root cause analysis, and implement corrective actions that ensure Denali’s products and services meet customer and compliance requirements.

Essential Functions:

• Assist in implementing and maintaining Denali’s QMS in alignment with ISO 9001 and customer-specific requirements
• Support the integration of PLM capabilities, ensuring accurate control of drawings, BOMs, and change management across product and service lifecycles
• Manage document control processes, including creation, revision, approval, and archival of SOPs, work instructions, and quality records
• Maintain and update QMS documentation libraries, ensuring accessibility and compliance with revision standards
• Collaborate with engineering, configuration, and operations teams to define inspection criteria, test plans, and acceptance procedures for incoming, in-process, and final products
• Develop and implement process quality controls that ensure repeatability and consistency across Denali's global operations
• Support Failure Mode and Effects Analysis (FMEA), process capability studies, and control plans for critical operations
• Ensure calibration and maintenance of inspection tools and testing equipment used in configuration or production environments
• Conduct process walk-throughs and line audits to validate adherence to SOPs and quality standards
• Collect, analyze, and report on quality data, including defect rates, yield, RMA trends, first-pass success, and audit findings
• Build and maintain dashboards to visualize quality performance across business units and identify trends requiring corrective action
• Support the development and tracking of KPIs aligned with Denali's Quality Objectives and continuous improvement roadmap
• Present data-driven insights to leadership during operational and management reviews to guide decision-making
• Investigate product or service nonconformances through structured root cause analysis methodologies (5 Whys, Fishbone, Pareto, etc.)
• Document, track, and verify closure of Corrective and Preventive Actions (CAPAs), ensuring timeliness and effectiveness
• Support planning, scheduling, and execution of internal audits across all quality-critical processes
• Assist in preparing documentation and objective evidence for third-party or certification audits (e.g., ISO 9001, customer audits)
• Track and verify closure of audit findings and opportunities for improvement
• Collaborate with Supply Chain to monitor supplier quality performance, including defect rates, on-time delivery, and RMA responsiveness
• Support supplier onboarding and qualification processes by reviewing quality documentation and conducting remote or on-site evaluations
• Identify opportunities for process and system improvement across Denali's operational ecosystem
• Support training and communication initiatives to drive awareness and adoption of best practices
• Contribute to post-project reviews by capturing lessons learned and quality performance outcomes
• Provide training to internal teams on quality procedures, inspection techniques, and documentation requirements
• Develop visual aids, job aids, and templates that support consistency across teams and functions

Competencies:

1. Ensures Accountability
2. Tech Savvy
3. Communicates Effectively
4. Values Differences
5. Customer Focus
6. Resourcefulness
7. Drives Results
8. Plans and Prioritizes
9. Decision Quality
10. Self-Development

Work Environment:

This position is based in a professional office setting and regularly utilizes workplace technology, including computers, smartphones, multifunction printers, cloud-based filing systems, and collaboration tools.

Physical Demands:

This role requires physical capabilities that support the successful execution of key responsibilities. The employee regularly engages in verbal and written communication with colleagues and clients to address project-related inquiries and must be able to convey accurate information clearly and efficiently. The position involves remaining seated at a workstation for approximately 75% of the time, with occasional movement throughout the office to access equipment, supplies, and shared resources. Daily tasks include consistent use of computers and standard office technology such as keyboards, printers, and multifunction devices. The role also involves transporting equipment boxes weighing up to 25 pounds within the building and to other offsite locations as needed for project support.

Required Education and Experience:

• Bachelor’s degree in Engineering, Quality, Industrial, or related technical field
• 4-7 years of experience in quality engineering, process quality, or operational excellence in technology, manufacturing, or managed services   

Qualifications:

• Working knowledge of ISO 9001 standards, audit practices, and CAPA systems
• Proficiency in QMS/PLM or ERP systems (e.g., Propel, Arena, D365, or equivalent)
• Strong analytical and statistical skills; experience with Excel, Power BI, or similar data tools for reporting and visualization
• Familiarity with Lean Six Sigma principles (Green Belt or higher certification preferred)
• Excellent communication, collaboration, and organizational skills
• Experience supporting global or multi-site operations a plus

AAP/EEO Statement:

3MD Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expression, veteran status or any other category that is protected by applicable law.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.