F&M Plastics, Inc. ยท 5 hours ago
Quality Engineering Manager
Osceola, WI
Full-time
Onsite
Mid, Senior Level
5+ years expF&M Plastics, Inc. is seeking a Quality Engineering Manager responsible for creating, designing, implementing, and maintaining quality processes to ensure products meet customer specifications and comply with ISO 13485 requirements. This role involves serving as the primary representative during audits and ensuring continuous compliance and improvement across the quality management system.
ManufacturingPlastics and Rubber ManufacturingPrintingSales
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
Qualification
Required
Bachelor's degree in Engineering or a related field
A minimum of 5 years related experience in a fast-paced manufacturing environment
Possess comprehensive knowledge of standard practices used in the engineering trade
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
Preferred
Previous ISO:13485 or ISO:9001 experience preferred
Company
F&M Plastics, Inc.
F&M Plastics is a leader in plastic dip-molding & coating, Punching, Pad Printing, and Urethane molding & coating.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase