Job Description

Job Title/High-Level Position Summary:

The Quality Assurance Manager is responsible for managing, developing, implementing, and maintaining technical systems and activities for a small Quality Assurance and/or Quality Control group.

Key Responsibilities:

• Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing and evaluating the quality, precision, accuracy and reliability of company products.
• Ensures compliance with Company standards and government regulations.
• Participates in the reviewing and assessing of engineering designs.
• Assists product support areas in gathering and analyzing data.
• Responsible for monitoring and reporting on product quality, performance and reporting on this through management review.
• Candidate must have a strong understanding /knowledge of FDA device requirements, ISO 13485, MDSAP and will be required to represent the business in audits of these areas.
• It is essential that they have a solid understanding of root cause analysis, CAPA and none-conforming product management.
• Has typically authority of a manager including hiring, disciplining, and terminating.
• Has budgetary responsibility.

Minimum Qualifications:

• 8+ Yrs of Work Exp in QA with a specific focus on Medical Devices
• BS/BA

Desired Characteristics:

• 5+ yrs of mgmt. exp

Lean or 6 Sigma Certification

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