NEW JOB OPENING
REQUIREMENTS ANALYST
IN Covington, GA, USA!

***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.**