The Quality Manager is responsible for overseeing and managing the quality assurance and control processes within the organization. This role involves developing and implementing quality standards, procedures, and systems to ensure that products or services meet or exceed customer expectations.
Lead, manage and motivate a team of Quality Engineers.
Foster a positive and collaborative work environment.
Provide coaching, mentorship and training to team members.
Key Functional Ownership
Manage the maintenance and improvement opportunities for both ISO 13485 and AS9100 Quality Management Systems.
Major Duties and Responsibilities:
Implement quality programs through the product realization phases covering the process from raw materials, materials in process, and finished product produced by the contract services team.
Manage & assign daily tasks and projects for the Quality Engineering staff.
Train staff in the use of quality tools to strengthen their knowledge and understanding of GMP.
Train personnel as needed to implement, strengthen, and maintain the Quality System for critical procedures and work instructions.
Work with customers to determine CTQ criteria for product quality and implement a defined quality plan to be used to monitor manufacturing.
Represent business during ISO registrar surveillance and recertification audits.
Serve as the Lead Internal Auditor
Review inspection reports & sign-off on Certificates of Conformance
Manage and resolve Non-Conforming and CAPA actions, including root cause analysis, failure mode and effects analysis (FMEA), and the control of nonconforming material.
Assist production personnel with operating equipment used to inspect product.
Communicate progress of projects to appropriate managers and staff.
Continuously strive to improve personal and group performance.
BS in Engineering or related sciences
ASQ – Certified Quality Engineer preferred
5+ years’ experiencein medical device manufacturing
Thorough understanding of ISO 13485-2016 Quality Standards and ISO AS9100 Quality Standards
Experience as Lead Internal Auditor
Experience training personnel on Quality matters
Experience with FDA approved facilities and regulatory requirements a plus.
Proven ability to read and interpret blueprints (drawings), including geometric dimensioning and tolerance standards.
Trained in statistical & production tools such as SPC, D.O.E., GMP
Excellent verbal and written communication skills
Strong knowledge and usage of Jump, MiniTab, MS Windows ™, Excel, AutoCAD, SharePoint, and Monday.com
Significant periods of standing and walking on hard surfaces.
Frequent movement between workstations, machinery or production lines.