Quality Manager

Job Description

Job Description

Job Overview

We are seeking a dynamic and detail-oriented Quality Manager to lead our quality assurance and control initiatives across manufacturing operations. In this pivotal role, you will champion the development, implementation, and continuous improvement of quality systems to ensure our products meet the highest standards of safety, compliance, and excellence. Your leadership will drive a culture of quality, foster collaboration across departments, and uphold regulatory requirements such as ISO 9001 and ISO 13485. If you thrive in a fast-paced environment and are passionate about delivering top-tier products through rigorous quality management, this opportunity is for you!

Primary Responsibilities:

· Report to senior management on the performance and improvement needs for the Quality Management System and the processes held within.

· Ensure the processes needed for the Quality Management System are established, implemented, maintained and improved.

· Ensure the promotion of regulatory awareness and customer requirements throughout the organization.

· Influence and encourage all in the organization to a positive, quality focused culture where everyone participates as a team in process improvements to reach company goals.

Operational Responsibilities:

· Ensure the training program is successfully developed, implemented and proven effective.

· Effectively manage the internal audit, NMR, CAR, PAR processes and the Continuous Improvement Program.

· Implement and maintain effective inspection processes to detect and prevent defects.

· Mentor, train, develop, motivate and lead your team of Inspection personnel and Quality Engineer(s).

· Perform other tasks and duties that may be assigned by the Director of Operations or CEO.

· Ensure compliance to most recent standards of ISO 9001 and ISO 13485

Success for this position looks like:

· Our company’s objectives, as defined within the Quality Management System have been met and are exceeded year after year.

· You have mentored and developed your team to be successful in their functions with or without your presence.

Qualifications

· 2-5 years of experience in a quality or inspection position

· Experience with ISO 9001 and/or ISO 13485

· Preferred manufacturing environment and management experience