Quality Engineer - US Tech Solutions, Inc.

Duration: 12-month contract with Extension
 
Job Description:

• Generates, reviews, and maintains division level 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. Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
• Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
• Acts as a lead auditor for division internal audit program.
• Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
• Supports or leads continuous improvement initiatives for quality management system processes.
• Assists with regulatory activities.

 
Experience:

• Previous experience using ETQ software preferred
• Proficiency in Microsoft office
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge
• Internal auditor experience and/or training
• Must be detail oriented and accurate
• Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
• Ability to work across matrix organizations and external consultants.
• Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.

 
Education:

• Bachelor’s Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
• Master’s Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).

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