Quality Assurance Director

Job Summary

The Quality Assurance Director position is one of stature and independence which will establish the company's Quality Assurance program.  Primary responsibility is ensuring products meet product specifications / requirements for release from development and all production shipments.  Establish a corrective action / preventative action program to be integrated with product performance in the field. Manage the coordination and control of supplier quality, safety compliance, calibration, internal audits and other quality functions as needed. Evolve the company from prototype assembly to professional commercial operations with a robust quality program. Provides support to project management, engineering, applications, production, configuration management and other groups outside of quality. Direct line access to Executive Staff and CEO.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Independent responsibility for assuring all product hardware, software and applications performance requirements as stated in requirements documents and marketing collateral have been achieved for commercial launch of new products.
• QA approval of all subassembly materials, finished goods, and delivery of products to performance metrics to market.
• Develop and maintain corporate quality manual and processes.
• Continuous employee training on quality processes.
• Establish information flow of all field activities to fully implement quality programs.
• Review and approve test plans and test results leading to a product release to market.
• Establishes and reports quality metrics of all products.
• Develops continuous quality improvement programs.
• Participate in root cause analysis of anomalies on production lines.
• Maintain tool calibration system integrity.
• Participate in project teams to design in quality assurance.
• Responsible for all compliance testing and approvals as applicable to product lines and intended markets.
• Perform other related duties as assigned.

 

EDUCATION and EXPERIENCE

• B.S. degree or equivalent in hardware engineering or physical science.
• 8 years experience in quality assurance, ideally having held a QA leadership role in product development life cycle and commercialization.
• Hands on experience developing a quality assurance program
• Proven ability to work in a fast paced, cross-functional, and changing environment for the purpose of developing troubleshooting test cases that demonstrate conformance to hardware specifications.
• Must be highly organized, hands on and goal oriented with attention to detail.
• Inspired by building systems, growing with a company and working amongst a strong intellectual team.
• Motivated by the pursuit of excellence.
• Knowledge of the overall regulatory and safety requirements associated with the development, production and sale of diagnostic instrumentation into worldwide markets.
• Experience with PC software driven, electro-mechanical optical systems.
• Ability and confidence to hold company accountable and enforce quality system.
• Ability to lead and motivate others with superior written and oral communication skills.
• Strong working knowledge of life science hardware verification and validation requirements.

 

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