Job Description
Title: CAPA Manager - Quality Review Board
About Us: GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.
GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer.
Role Summary/Purpose: In this role, CAPA Manager is responsible for creating and supporting a Quality culture across sites by driving compliance activities around the CAPA Program, managing continuous process/quality improvements and demonstrate compliance during internal and external audit/inspection opportunities.Essential ResponsibilitiesBuild your career and experience the advantages that come with working for one of the "World’s Most Admired Companies" (Fortune Magazine) offering significant opportunities for growth and career advancement!
Primary responsibilities include:
Lead CAPA (Corrective Action, Preventative Action) activities, to include, but not limited to:
* Coordination/management of overall CAPA process, including control of nonconformances and/or Quality Review Board activities.
* Interfacing with other CAPA Manager, Post-Market RA Manager, Engineering, Manufacturing, Clinical, QA/RA, and Service, to ensure system issues are identified and addressed.
* Driving solid root cause analysis methodology throughout process.
* Ensuring timely and effective CAPA relating to product and process identified issues by working closely acrossfunctions.
* Completion and presentation of on-going CAPA metrics to management both at business and corporate levels.
* Ensure regulatory compliance and optimization of CAPA procedures through:
- Development, maintenance and improvement of documented processes
- Development and implementation of employee training
- Development and implementation of quality metrics to drive improvement and business results
* Lead/Support key QA/RA activities, as assigned. May include, but are not limited to activities in the following areas:
- CAPA investigations
- Training
- Internal Auditing
- Data Analysis Reviews (QDAR, QMR)
Qualifications/Requirements:
* Bachelor’s degree (or high school diploma/GED plus 8 years experience work experience).
* Minimum 3 years experience in a medical device or pharmaceutical industry.
* Minimum 3 years experience with CAPA systems.
* Minimum 3 years experience applying regulations (including FDA QSRs, ISO13485).
* Ability to work independently in fast-paced environment with little supervision.
* Ability to identify root cause of problem, and creatively problem solve to gain resolution.
* Ability to communicate effectively in English (both written and oral).
* Ability to adapt to constant change.
* Team-oriented and responsive to customer needs.
* Strong problem solving and analytical skills.
* Quality focused, attentive to detail and results oriented.
* Ability to influence positive change effectively.
* Must submit application for employment through gecareers.com (or COS if internal) to be considered.
* Must be 18 years of age or older.
* Must be willing to take a drug test as part of the selection process.
* Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.
* Excel proficient to facilitate data analysis work.
* Must have unrestricted legal authorization to work in the United States.
* Must be willing to work in Salt Lake City, Utah.
Additional Eligibility Qualifications GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics
1. Auditor Certification
2. Familiar with continuous improvementmethodologies, including Lean
3. Experience with training and course development
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