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:
Lean or 6 Sigma Certification
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