Quality Assurance Manager

Job Title: Quality Assurance Manager

Reports to: President & CEO

Summary/Objective

The Quality Assurance Manager is the advocate for the customer and ensures that customer quality and regulatory requirements are met for all products produced. They act as the management representative for all ISO9001 and AS9100 requirements, related correspondence and processes, and as the direct contact for customers regarding quality.

Essential Functions

Have a thorough understanding of the requirements the QMS standard as well as customer quality requirements. Serve as the primary point of contact with the auditor from the certification body or customer during ISO 9001/AS9100 quality audits. Improve our QMS by providing effective corrective actions for audit findings and recommendations for improvement. Ensure the quality management system is operating effectively.

• Lead problem solving and root cause analysis related to deficiencies in the QMS. Apply sound, systematic problem-solving methodologies to determine and implement effective corrective actions to address identified deficiencies.
• Serve as the management representative for quality assurance
• Be an effective member of the leadership team, enforce compliance and foster continuous quality improvements.
• Work with management, production and engineering personnel to improve operational procedures, and provide leadership for improvement projects relating to the QMS.
• Maintain document control processes, evaluate and make improvements as necessary.
• Serve as the regulatory compliance manager. Establish and enforce policies for compliance with regulatory requirements such as REACH, RoHS and Conflict Minerals.
• Supervise and manage subordinate reports as assigned.

Competencies

• Extensive knowledge and experience with ISO 9001/AS9100 standards and regulatory requirements.
• Ability to build strong and collaborative relationships with management, peers and direct reports.
• Problem solving skills to identify root cause and develop effective corrective actions.
• Possess strong organizational skills and is detailed oriented.
• Must have strong verbal and written communication skills, work well with diverse groups of people and be able to function independently of direct supervision.
• Provide timely and effective performance management to direct reports. Address conflict and work to resolve differences proactively.
• Advanced computer skills using Microsoft Office applications.
• Knowledge of ISO 13485 a plus.

Supervisory Responsibility Provide supervision and direction to QA personnel.

Position Type/Expected Hours of Work

This is a full-time position, and hours of work and days are Monday through Friday, 8:00 a.m. to 5:00 p.m.

Travel

Travel is expected 5% of the time. Some international travel may be required.

Required Education and Experience

• BS/MS degree or equivalent quality experience.
• 5+ years in quality assurance experience in manufacturing of products for aerospace, medical devices, or a similar regulated industry.
• Lead Auditor experience strongly preferred