Requirements Analyst Jobs in USA, GA, Covington | Rose International Job

• **Only qualified Requirements Analyst candidates located near the Covington, Georgia area to be considered due to the position requiring an onsite presence***

Education

Associate Degree in a science field

Preferred Certifications
American Society of Quality Certification ASQ Certified Quality Engineer CQE preferred
American Society of Quality Certification ASQ Certified Quality Auditor CQA preferred
American Society of Quality Certification ASQ Certified Quality Manager CQM preferred

Experience
Experience working in a regulated industry environment
Experience performing laboratory testing and investigations
Experience supporting complaint investigations and quality activities
Experience working with manufacturing processes and quality systems
Experience with Good Manufacturing Practices GMP and Good Laboratory Practices GLP
Experience analyzing data and preparing investigation documentation
Experience working with regulatory requirements and quality standards
Prior laboratory experience preferred

Tech Skills
Complaint investigation and documentation
Laboratory testing and bench methods
Laboratory instrumentation operation and maintenance
TrackWise complaint management system
Microsoft Excel including Pivot Tables and VLOOKUP
Data analysis and reporting
Quality systems and regulatory compliance
ISO standards knowledge
FDA guidelines knowledge
OSHA requirements knowledge
Quality Systems Regulations QSR knowledge
Technical report writing
Product testing and evaluation

Soft Skills
Strong attention to detail
Excellent verbal and written communication skills
Presentation skills
Time management and prioritization
Ability to manage multiple assignments
Critical thinking and problem solving
Sound judgment and decision making
Ability to work independently with minimal supervision
Strong organizational skills
Ability to collaborate with cross functional teams

Physical Demands
Ability to sit walk talk and hear regularly throughout the workday
Ability to move throughout a laboratory environment
Ability to perform close vision and color vision activities
Ability to occasionally lift up to 25 pounds
Ability to work in a biohazard environment while following safety procedures

Responsibilities
Perform product testing within the complaint laboratory
Plan organize track and document complaint investigation activities
Support project teams and quality department initiatives
Conduct complaint investigations for products and related manufacturing activities
Create and manage investigation files within the complaint management system
Coordinate investigations with manufacturing sites to ensure timely completion
Set up operate maintain and troubleshoot laboratory equipment and testing instruments
Perform testing in accordance with GMP and GLP requirements
Maintain accurate testing data and assist with data analysis and conclusions
Provide quality engineering support to resolve quality issues
Ensure compliance with departmental divisional and regulatory procedures
Interface with manufacturing suppliers and product support groups
Present findings to engineering management and peer groups as needed
Support FDA reporting requirements through timely communication of findings
Maintain knowledge of quality standards regulatory requirements and company procedures

Required Qualifications
Associate Degree in a science field
Knowledge of medical device regulations industry standards or international standards
Knowledge of laboratory methods and instrumentation
Understanding of GMP GLP ISO FDA OSHA and QSR requirements
Proficiency with Microsoft Excel including Pivot Tables and VLOOKUP
Ability to analyze technical procedures and regulatory information
Ability to write reports and business correspondence
Ability to present information effectively to various audiences
Ability to manage priorities and multiple assignments

Preferred Experience
Laboratory experience
Medical device industry experience
Complaint investigation experience
Quality engineering support experience
Experience using TrackWise
ASQ certification

**Only those lawfully authorized to work in the designated country associated with the position will be considered.**
**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit

here
. Should you have any questions/concerns, please contact our HR Department via our secure
website

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website

here

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise,

please contact our HR Department

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).