Manager, Quality Corrective and Preventive Actions

Quality Assurance Aliso Viejo, California Ft Myers, Florida Houston, Texas Flexible


Description

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.  

We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety of HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture!  

NeoGenomics is looking for a Manager, Quality Corrective and Preventive Actions who wants to continue to learn in order to allow our company to grow.  

Flexible work arrangement, with 3 days/week onsite expectation.  

Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:  

As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory.  

Position Summary:  

This is a management role accountable for global oversight of the Investigation and Corrective Action/Preventive Action (CAPA) system and processes including customer complaints, monitoring process performance, and implementing continuous process improvements.  

Core Responsibilities:  

 Provide Corrective and Preventive Action (CAPA) process leadership driving improvements in product and process performance, and elimination of waste  

Ensure that direct reports are trained, competent, and employ safe practices in the execution of their duties  

Develop a plan to bridge improvement gap between CAPA vision and current state  

 Coordinate and monitor the Company's CAPA program to assure CAPAs are properly generated, and that corrective or preventive actions are identified and effectiveness checks successfully completed in a time frame consistent with Company policy  

 Leads global site complaint and CAPA continuous improvement projects  

 Develop and implement complaint/CAPA-related data collection systems and other strategies that optimize statistical efficiency and data quality  

Develop and implement an ongoing education process for the CAPA / complaint process  

 Employ risk analysis tools to determine appropriate internal and external corrections, corrective actions, and/or preventive actions required  

 Utilize, lead, and facilitate formal Root Cause analysis/techniques  

Thoroughly document all aspects of the investigation, complaint, and CAPA process to develop an audit-ready record  

Complete Quality Management Systems CAPAs in an efficient and effective manner in order to meet the company's metrics for the effectiveness of the CAPA process  

Facilitate training when changes are made to the process, procedure, or MasterControl system  

Participate as a CAPA subject matter expert during internal and external audits  

 Management of CAPA Review Board (CRB), and relevant portions of Management Review (MR) data presentations  

Knowledgeable of federal and state laws and regulations concerning clinical laboratory testing procedures and results. (CAP/CLIA, NYDOH, ISO 15189/13485, 21CFR820)  

Up to 25.00% domestic/international with some overnight travel may be required.  

Requirements:  

Bachelor’s Degree preferably in Life Sciences, Engineering or an equivalent field of study.  

A minimum of 5 years proven record of success in quality management  

A minimum of 3 years performing CAPA investigations, documentation and performing effectiveness verifications of CAPAs  

Six Sigma Certified Green Belt/Black Belt, preferred  

ASQ CQE, CQA, or CQM/OE, preferred  

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

Pay Range (will vary based on location & experience) $104,470 – $180,211 annually, plus bonus