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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Kibbutz Shefayim, Center District, Israel
Job Description:
About Johnson & Johnson** MedTech**
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a CQ Staff Specialist EP role, to join our team located in Shefayim, Israel.
**Purpose: **Under the general direction of the Lead Commercial Quality Electrophysiology Mid-size markets cluster, this position is responsible for establishing and leading Johnson & Johnson overall quality management framework and quality system for Electrophysiology business in Israel, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities.
The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals. Role complexity includes but is not limited to ability to interact cross functional and representation of the country in global projects and initiatives.
The lead is responsible to lead activities towards the integration of the quality management systems for Electrophysiology in Israel. This position is responsible for ensuring the QMS requirements are effectively executed in the country in accordance with local regulations, corporate and segment policies and procedures.
The role will interface with related organizations to ensure a consistent and systematic process is followed and that metrics are reported timely.
You will be responsible for:
- Serve as an SME (Subject Matter Expert) for the assigned Quality System processes e.g. Document & Record Management, Quality Agreements, Change Control, Audit & Inspection, Repack Relabel, Purchasing Controls, CAPA etc…
- Provide guidance and support and coaching on assigned processes & systems.
- Ensure adequate communication of quality compliance needs and status to all affected sites/organizations.
- Drive simplification, standardization and continuous improvement of processes across the EMEA region.
- Ensure timely and consistent reporting of metrics and KPIs (Key Performance Indicators) associated with assigned processes.
- Provide regional audit/inspection readiness support.
- Builds strategic partnerships regionally and globally, and support development of solutions and ensure implementation with region.
- Conducts supplier and distributor audits; 3PL audits. Tracking of the follow-up activities to address observations after the audits
- Manages product quality complaints and adverse events process in liaison with franchise quality team, local commercial team, distributors and brand protection
- Ensures compliant and timely Field Action execution.
- Drive complaint vigilance execution in the countries, where applicable, ensuring the timely closure of product related complaints cases, quality, and immediate escalation.
- Understand current requirements of Regulatory Agencies such as local MOH’s, as well as, of standard organizations such as ISO.
- Monitors compliance with company policies and J&J quality procedures
- Evaluate quality processes and recommend improvements to meet regulatory requirements
- Ensure compliance with Country applicable regulation.
- Monitors trends, identifies issues, recommends and implements appropriate actions. Assists in the development, implementation and review of standard operating procedures.
- Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time
- Perform other related duties as required
Qualifications and Requirements:
- Bachelor’s degree in engineering, scientific, business or QRC disciplines. Will accept the equivalent relevant industry experience if no degree.
- Compliance experience, QMS experience.
- Change management and project management experience.
- Strong presentation skills.
- Collaborative approach, team player.
- Managing complexity, working in a matrix organization.
- Detailed understanding of QM Systems and local/regional (EMEA) Medical Device regulations.
- +5 Years experience in regulated industries; medical device / pharma / consumer.
- Experience with ISO certification, Notified body; Health authority inspection experience.
- Understanding the linkages in Quality and Regulatory compliance in delivery to customer and health authority.
- Excellent level of spoken and written English and Hebrew
#LI-AB6
#LI-Hybrid
**Required Skills: **
Preferred Skills:
Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)