Requirements Analyst GA, Covington

Position: Requirements Analyst Jobs  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

Track Wise 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 Track Wise

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…