Quality Systems Program Lead
Location: Mission Viejo
Posted on: February 22, 2021
Are you motivated to participate in a dynamic, multi-tasking
environment? Do you want to become part of 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. NeoGenomics is
looking for a Quality Systems Program Lead who wants to continue to
learn in order to allow our company to grow.
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: As aQuality Systems Program Leadyou
will be accountable for global oversight of the Non-Conformance
(NC), Corrective Action/Preventive Action (CAPA) system, customer
complaints, and Management of data across the Quality Management
Systems. You will assist with maintaining the global
NCEs/CAPA/Customer complaints processes including the monitoring
process performance and implementing continuous process
improvement. Non-Conformance & CAPA Process Management
- Assists with daily operational aspects of the Non-Conformance
- Employ risk analysis tools to determine appropriate internal
and external corrections required
- Develop and employ sound investigative techniques to fully
understand and document problems
- Utilize, lead, and facilitate formal Root Cause
- Thoroughly document all aspects of the CAPA process to develop
an audit ready CAPA record
- Work with cross-functional teams throughout CAPA process to
ensure effective outcomes
- 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
- Coordinate and monitor the Company's CAPA program to assure
CAPAs are properly generated, and that corrective or preventative
actions are identified and effectiveness checks successfully
completed in a time frame consistent with Company policy.
- Collaborates with the Quality Management team to review and
finalize monthly and quarterly NC/CAPA metrics. Run ad hoc reports
- Participates in global site NC/CAPA continuous improvement
- Determine, Develop, and provide general training to the global
NC/CAPA team and other applicable users as necessary.
- Facilitate training when changes are made to the process,
procedure, or MasterControl system.
- Participates as a NC/CAPA subject matter expert during internal
and external audits.
- Lead the implementation and maintenance of a paperless NC/CAPA
- Lead process performance review meetings with the global
- May act as delegate to lead Corporate CAPA Review Board
- Identify and assist with the implementation of updates to the
NC/CAPA MasterControl module; including participating in validation
efforts. Management of Quality Management Systems Data
- Develop and implement data collection systems and other
strategies that optimize statistical efficiency and data
- Acquire data from primary or secondary data sources and
maintain databases/data systems.
- Identify, analyze, and interpret trends or patterns in complex
- Interpret data, analyze results using statistical techniques
and provide ongoing reports.
- Management of CAPA Review Board (CRB) and Quality Review Board
(QRB), Management Review (MR) data presentations General Quality
Management Systems Support
- Assists in the preparation and execution of site Management
- Participates as a site internal auditor for the program
- Maintains good knowledge of laboratory & medical device
standards / regulations.
- Knowledgeable of federal and state laws and regulations
concerning clinical laboratory testing procedures and results.
(CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820)
- Responsible for the monitoring, tracking and communication of
issues, as well as, documentation of policies and procedures as it
pertains to the QMS. Experience & Required Qualifications:
- Bachelor's Degree, preferably in the Life Sciences, Engineering
or an equivalent field of study.
- Minimum of 3 years of experience performing CAPA
investigations, documentation and performing effectiveness
verifications of CAPAs.
- Minimum of 3 years supporting a global Non-Conformance/CAPA
process in the medical device or healthcare industry or laboratory
- Experience in FDA regulated industry required, specifically
knowledge of applicable regulations, i.e. current Good
Manufacturing Practices, Quality System Regulations, and ISO
- Knowledge of and the ability to translate and apply the
requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical
Device Single Audit Program (MDSAP).
- Project Management Experience preferred.
- ASQ Certified Quality Auditor preferred
- Must exhibit strong and effective communication skills.
- Must have excellent and effective writing skills.
- Must be able to maintain a high activity level, and be able to
effectively lead and prioritize numerous projects and
responsibilities. 5-10% domestic/international with some overnight
travel may be required. 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. NeoGenomics
endeavors to make www.neogenomics.com/careers accessible to any and
all users. If you would like to contact us regarding the
accessibility of our website or need assistance completing the
application process, please contact our EEO Coordinator at
866-776-5901 option 0 or HR@neogenomics.com . This contact
information is for accommodation requests only and cannot be used
to inquire about the status of applications. Statement to ALL
Third-Party Agencies and Similar Organizations: NeoGenomics accepts
resumes only from agencies with which we formally engage their
services. Please do not forward resumes to our applicant tracking
system, NeoGenomics employees or hiring managers, or send to any
NeoGenomics facility. NeoGenomics is not responsible for any fees
or charges associated with unsolicited resumes. You have been
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Keywords: NeoGenomics, Mission Viejo , Quality Systems Program Lead, Other , Mission Viejo, California
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