Job Description

Duration: 09 months contract

Job Description:

• Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Initiates Change Controls and Document Change Requests to update procedures and processes.
• Works within departments and with various departments to update processes and procedures.
• Assists in managing the document review and retention processes.
• Supports or leads continuous improvement initiatives for document control related processes.
• Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)

Experience:

• 2+ years related experience required
• Prior experience in a manufacturing environment is preferred.
• Previous experience using ETQ or other Document Management software preferred
• Experience in ISO 9001 or other Quality System standards
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
• Must be detail oriented and accurate in execution of work
• Able to work well both independently and in a group setting
• Proficiency in Microsoft office

Education:

• Associate or bachelor’s degree in life sciences, engineering, or a related field preferred.

Skills:

• Documentation, 21 CFR, ETQ, QMS, Quality Management System, ISO 9001, ISO 13485

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Alok

Email: alok.s@ustechsolutionsinc.com

Internal Id: 25-30768

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