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

Job Description
***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.).