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Skills

Quality Assurance and Validation Specialist

I. JOB DESCRIPTION:
Reporting to the Director of Global Vigilance, Quality Administration, the Quality Assurance and Validation Specialist is responsible for implementing design and process verification and validation plans for medical devices (embedded software, hardware, and integrated systems). The position is within the Quality department and will require working with Engineering, QA/RA, and Product Reporting personnel.

II. PRINCIPAL DUTIES & RESPONSIBILITIES:
• Contributing to the development of Requirements, Specifications, and Validation documents
• Developing Test scripts based on Software, Hardware and System level requirements
• Developing and executing Design Verification and Validation protocols and reports for Software, Hardware, and Integrated Systems
• Writing verification and validation reports
• Authoring, reviewing and approving validation documents developed by the Product Reporting Department, ensuring the documentation meets regulatory requirements and quality standards.
• Initiating Risk Assessments on current systems.
III. JOB DEMANDS:

This job requires the Quality Assurance and Validation Specialist to have the ability to handle multiple projects and execute in a timely manner. The Quality Assurance and Validation Specialist must maintain a professional manner and demonstrate initiative and self-direction. This person must also be able to handle competing priorities and executing projects with tight deadlines.

IV. JOB QUALIFICATIONS:

Required experience: Validation, software validation, computer system validation, 21 CFR Part 11: Minimum 5 years

• Thorough knowledge 21 CFR Part 11 regulations and guidelines
• Thorough knowledge of IT Controls methodologies
• Excellent communication skills, both verbal and written
• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
• Knowledge of general software and database concepts
• Experience with risk analysis and risk management practices and tools
• Knowledge of infrastructure technology and platforms
• The ability to work both independently and with teams at various levels in the organization
• Excellent organizational skills and attention to detail and accuracy
• Five or more years of experience in computerized system validation within a regulated environment
• Knowledge of Relsys EasyTrak SAP integrations and Crystal Reports a plus.

V. EDUCATION
• Required: Bachelor's degree in Computer Science or Engineering discipline
• Preferred: Advanced degree in related technical field.

Thanks & Regards

Smith,

Sr. Technical Recruiter

Infotree Service Inc.

215 Ann Arbor Rd.

Suite 304

Plymouth, MI 48170

734-446-7070

Fax- 734-345-4247

smith@infotreeservice.com