Quality Manager Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering, Quality Management or a related technical discipline preferred.
• Minimum 10 years of related experience in QA/QC management with a manufacturing or production environment.
• Strong working knowledge of ISO 9001 and ISO 13485 Quality Management Systems and quality principles.
• Advanced proficiency with Root Cause Analysis (RCA) Failure Mode and Effects Analysis (FMEA) and Statistical Process Control (SPS)
• Must have excellent verbal and written communications abilities with a proven skill in translating quality data into actionable executive presentations.

Responsibilities

• Lead the program and maintenance of the QMS in full alignment with the ISO 9001 and ISO 13485 standards.
• Act as primary point of contact for external auditors, certification entities and customers representatives during quality audits.
• Assist the process Champion using risk-based thinking per ISO guidelines to identify areas for operational improvement, optimizing cost efficiencies and reduction of scrap and rework.
• Oversee document control ensuring that standard operating procedures (SOP’s), work instructions and quality records remain accurate, traceable and compliant with ISO specifications.
• Partner with leadership, operations and procurement teams to embed a quality culture and integrate ISO 9001 and ISO 13485 standards into daily workflows.
• Plan and execute comprehensive internal audit programs to ensure adherence to QMS, ISO 9001 and ISO 13485 guidelines.
• Manage the Corrective and Preventive Action (CAPA) system to investigate root causes, implement solutions and verify effectiveness.
• Track, analyze and report QMS performance data to senior leadership and drive evidence-based decision making and continuous quality growth.
• Review contracts, product specifications, customer requirements and contractual obligations to ensure all products consistently meet or exceed applicable quality standards, customer expectations and regulatory requirements.
• Other duties as assigned.

Benefits

• Basic Life Insurance at no cost to the employee
• 401(k) with match and Surplus-Sharing Plans
• Health, Dental, and Vision Insurance
• Ten paid holidays annually
• Paid Time Off (PTO)
• On-site Health and Wellness program
• Employee Assistance Program (EAP)