CAPA & Training Leader

Job description

3423028
Additional Cities

Haifa
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

Israel
Postal Code

30200
Role Summary/Purpose

The CAPA Leader is responsible for oversight of the CAPA process and CAPA Review Boards, to ensure that all areas of the QMS are analyzed / evaluated for input to the CAPA process, problems are escalated and documented appropriately, and that regulatory requirements are met.
Leads processes to drive improvements. Support problem records owners while maintaining site QMS (MDSAP regulation; ISO13485), provide quality professional direction and support.
Essential Responsibilities

Under Training: Responsible for development and implementation of employee training, ensure training programs are current and employees are assigned and trained on time.
Managing local Work instructions and retention.
Support internal Audit program at site.

Responsibilities:
1. Lead the CAPA Review Board (CRB) activity at site and support the global effort per HEHC meetings mechanism
2. Provide oversight and feedback for the CAPA process and input to the Quality Management Review (QMR).
3. Solid understanding of problem solving & root-cause analysis skills
4. Support problem record users with CAPA framework process: NCs, investigation, CAPA, including evaluation process and all documentation requirements/expectations.
5. Support the development, implementation, and continuous improvement of process effectiveness and efficiency at the site
6. Verify expected documentation level in each Problem Record (PR).
7. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
8. Facilitates the suppliers CAPA review board, map and identify process improvements.
9. Focal point of contact with actual and potential problem records.
10. Utilizes 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
Qualifications/Requirements

1. Bachelor's Degree or a minimum of 4 years work experience in Device companies (ISO13485; FDA, CMDCAS, TUV, ANVISA).
2. Minimum of 4 year experience working in a regulated industry or a Master’s degree
3. Ability to communicate effectively in English (both written and oral).
4. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
4. 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.
5. Demonstrated collaboration, negotiation & conflict resolution skills
6. Excellent communication skills (written and oral)
7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
8. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
10. Experience leading and implementing change.
12. Ability to multi-task & handle tasks with competing priorities effectively
11. Experience performing internal audits and participating in external audits – Preferred.
About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
Primary Country

Israel
Primary State/Province

Haifa
Primary City

Haifa