Quality Engineering Manager

Description

Job Summary: 

This position is responsible for creating, designing, implementing, and maintaining quality processes to ensure products meet customer specifications and comply with ISO 13485 requirements. The role serves as the company’s primary representative during internal and external audits, regulatory inspections, and management reviews. This individual fully owns assigned processes, ensuring continuous compliance, effectiveness, and improvement across the quality management system.

Summary of essential job functions and responsibilities:

• Design, implement, maintain, and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements.
• Develop and maintain quality standards, procedures, and control systems to ensure products consistently meet customer and specification requirements.
• Serve as the Management Representative for ISO 13485, including preparation, execution, and follow-up of bi-annual management review meetings.
• Act as the primary representative during internal, external, regulatory, customer, and supplier audits.
• Plan, conduct, and manage internal and supplier audits, including audit reporting and corrective action follow-up.
• Direct and manage Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, including root cause analysis, implementation, and effectiveness verification.
• Analyze quality performance data, identify trends and risks, and present reports and recommendations to management.
• Lead continuous improvement initiatives to strengthen compliance, process effectiveness, and product quality.
• Collaborate cross-functionally with production, maintenance, suppliers, and other teams to resolve quality issues and prevent recurrence.
• Manage supplier quality activities, including evaluations, controls, audits, and performance monitoring.
• Coordinate directly with customers regarding quality concerns, complaints, and corrective actions.
• Manage internal and external complaints and customer feedback in accordance with ISO 13485 requirements.
• Oversee validation of new and existing equipment, processes, and changes prior to release for production use.
• Coordinate customer samples and ensure sample builds meet documented specifications and quality requirements.
• Assess and communicate quality-related impacts to production schedules, timelines, and costs to support management decision-making. 

Requirements

  Minimum Requirements:

• Bachelor's degree in Engineering or a related field.
• A minimum of 5 years related experience in a fast-paced manufacturing environment
• Previous ISO:13485 or ISO:9001 experience preferred
• Possess comprehensive knowledge of standard practices used in the engineering trade

Skills and Abilities Required: 

• Ability to work effectively in a shared work environment, demonstrating leadership within a team-based workforce.
• Strong interpersonal and communication skills when interacting with customers, employees, coworkers, and administrative staff.
• Excellent record-keeping, documentation, and attention to detail.
• Ability to collect, analyze, and interpret data to support decision-making and problem resolution.
• Strong decision-making and problem-solving skills.
• Effective organizational, planning, and multi-tasking abilities.
• Strong time management skills with the ability to prioritize workload and meet deadlines with a high degree of accuracy.
• Proficiency with computer programs including Microsoft Word, Excel, and enterprise systems such as Unipoint and JobBOSS.
• Ability to read and interpret blueprints, specifications, and technical documentation.
• Ability to work independently as well as collaboratively in team environments.
• Ability to perform effectively under deadlines and in high-stress situations.
• Ability to lift up to 20 pounds regularly and up to 40 pounds as required.
• Ability to reach, twist, bend, squat, push, pull, and climb as needed to perform job duties.

Work Environment:

• Occasionally exposed to seasonal temperature extremes (heat, cold, wet, and/or humid)
• Noise level is usually moderate (hearing protection available)