Quality Assurance Corrective and Preventive Actions (CAPA) Leader

Job description

3238030
Additional Cities

Florence
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

United States
Additional States/Provinces

South Carolina
Postal Code

29501-7806
Role Summary/Purpose

This position is responsible for leading the Corrective and Preventive Actions (CAPA) process in accordance with documented procedures and practices. This is a key compliance role responsible for the creation of NC’s, Investigations, and CAPA’s as required.
Essential Responsibilities

·  Assists record owners in ensuring 100 percent quality and regulatory CAPA compliance in accordance with documented procedures.
·  Leads, acknowledges, develops, communicates & implements a strategy to ensure CAPA compliance.
·  Coach/mentor CAPA record owners on the process and the use of quality tools.
·  Assists record owners on root cause analysis, left/right looks, and effectivity methodologies 
·  Drive NC, Investigation, and CAPA timeliness to meet corporate metrics
6. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). 
·  Guides record owners on using risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts.
·  Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
·  Facilitates CAPA Review Board (CRB)
Qualifications/Requirements

·  Bachelor's Degree or a
minimum of 4 years of related work experience.
·  Minimum of 1 year experience
working in a regulated industry or a Masters degree
·  Ability to communicate effectively
in English (both written and oral).
·  Demonstrated experience and proficiency
with MS Office word processing, spreadsheet, presentation, and database
applications.
Desired Characteristics

·  Minimum
of 3 years experience in a regulated industry is preferred
·  Demonstrated
understanding or aptitude to understand Medical Device QMS requirements and
regulatory requirements including but not limited to FDA CFR 21 820 and ISO
13485.
·  Demonstrated knowledge of Quality Management System tools, continuous
improvement methodologies & in-depth understanding of site level products
& related processes
·  Demonstrated expertise to effectively communicate
within all levels of the organization around concepts of design controls,
design verification and validation activities; production &process
controls; Corrective & Preventive Action (CAPA), complaints & risk
management; & product quality improvement using tools such as six sigma,
DFR, etc.
·  Demonstrated collaboration, negotiation & conflict resolution
skills
·  Excellent communication skills (written and oral)
·  Demonstrated
ability to lead, acknowledge, develop, communicate & implement a strategy
under crisis situations to ensure compliance
·  Demonstrated understanding of
continuous quality / process improvement tools: (As defined by the local site,
e.g. DMIAC, SPC, Lean SS, 5S)
·  Experience leading and implementing change
·  Experience performing internal audits and participating in external audits
·  Exceptional analytical, problem solving & root-cause analysis skills
·  Ability to multi-task & handle tasks with competing priorities effectively
·  Strong technical aptitude (i.e. able to read & comprehend technical
documentation & execute procedures), global regulatory experience &
demonstrated experience interfacing with regulators.

About Us

GE Healthcare provides transformational medical
technologies and services to meet the demand for increased access, enhanced quality and more affordable
healthcare around the world. GE works on things that matter - great people and technologies taking on tough
challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,
biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps
medical professionals deliver great healthcare to their patients.
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Healthcare

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening.
Primary Country

United States
Primary State/Province

South Carolina
Primary City

Florence