Job Seekers, Please send resumes to resumes@hireitpeople.com Primary Skills: SDLC, SW Quality Audits, life sciences or computer science
Description:
Client at Seattle, WA (direct hire) Quality Management System Manager, SDLC, SW Quality Audits, Life Sciences or computer science knowledge. Details follow.

Client is seeking an individual contributor who can provide quality system guidance and execution to applicable Development, Test and Information Technology areas. This role will coordinate implementation and maintenance of quality management system processes intended to satisfy regulatory and customer expectations. This position will work closely with Product Management and Development, Customer Support, Procurement, and Human Resources. 
Location: Seattle, WA 
Travel: 15% 
**This is a direct hire position 
**Candidate must have Life Science experience. 
**Candidate will be offered Salary (app. $150K/160K), benefits and stock options.
Interview: Phone/Skype and face to face most likely be required. 

The Quality Management System Manager must have proven leadership skills and proven expertise in quality management systems. The successful candidate will be able to monitor and assess regulatory impact on the clients products and processes, and provide guidance and oversight to applicable areas. 

Responsibilities: 
Implement and maintain the quality management system in compliance with the applicable standards and regulations. 
Implement and maintain the document control and learning management systems. 
Develop and deliver QMS and regulatory training programs to ensure compliance. 
Provides leadership in the identification and implementation of improvements for the quality processes. 
Develop and implement procedures and instructions to maintain the effectiveness of the quality management system. 
Participate and support external and internal audits. 
Liaison with regulatory agencies regarding compliance issues. 
Hire, train and develop quality systems personnel or contractors to effectively support and continuously improve the quality management system. 
Qualifications: 

A minimum of 8 years of experience implementing quality programs in high-tech software companies. 
Experience working under at least one of the following: GxPs, QSR, 21 CFR Part 11, ISO, and HIPAA/HITECH. 
**Deep understanding of SDLC and experience implementing QMSs into that environment. 
Experience leading Software Quality Audits for new and existing systems. 
Ability to lead cross-functional teams and collaborate closely with colleagues. 
Excellent Communication skills and ability to work with employees at all levels of the organization. 
Ability to prioritize in a results-driven, collaborative environment. 
Education: Bachelor's Degree. 
Ideal: 

Working knowledge in the areas of life sciences or computer science. 
Professional certification like CISA, CIA or CRISC.