Standards Quality Lead

Job description

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com
Job Function:
Quality
Job Sub Function:
R&D/Scientific Quality
Job Category:
Professional
All Job Posting Locations:
Yokneam, Haifa District, Israel
Job Description:
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular?

Ready to join a team that’s reimagining how we heal?

Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke.

You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
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 Standards Quality Lead to be in Yokneam.
This role is responsible for driving the implementation and maintenance of Quality & Compliance processes related to standards and regulations within New Product Development (NPD).

The position ensures alignment with internal Johnson & Johnson policies, global regulatory requirements, and industry standards.

It serves as a key interface between cross-functional teams to ensure product compliance, reliability, and quality throughout the development lifecycle.
Key Responsibilities:
Compliance with Standards & Regulations
* Lead the deployment of Quality & Compliance processes for new products, ensuring adherence to both internal J&J standards and external regulatory requirements.
* Provide technical support to hardware teams for safety, electromagnetic compatibility (EMC), and environmental testing at certified laboratories.
* Actively participate in the Global Standards Council quarterly meetings; review and analyze reports to identify relevant standards for inclusion in the Standards and Regulations Management Meetings.
* Organize and lead Standards and Regulations Management Meetings, ensuring effective tracking, assessment, and implementation of applicable standards.
* Conduct gap assessments against external and internal standards; initiate and follow up on corrective actions with Subject Matter Experts (SMEs).
* Notify SMEs of new or revised standards and coordinate related compliance activities.
* Drive completion of standards compliance activities in collaboration with SMEs and project teams.
* Maintain and update the Standards and Regulations Management SOP and the master list of applicable standards.
* Act as a Subject Matter Expert (SME) during internal and external audits, CAPA investigations, and updates to technical documentation.
Quality Integration in NPD
* Provide quality input to NPD Quality & Compliance deliverables, including Quality Plans and Critical to Quality (CTQ) parameters.
* Develop and implement methodologies to assess and improve product reliability and quality during development.
* Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, R&D, Clinical, and Medical Safety Office (MSO) to ensure comprehensive compliance and product excellence.
Qualifications:
Education:
* Required: Bachelor’s degree (BA)
* Preferred: BSc in Engineering, Mechanical Engineering, Quality, Statistics, or a related technical field
Experience:
* Proven experience as a Quality Engineer, ideally within the active medical device industry
* Strong understanding of regulatory standards (e.g., ISO, IEC, FDA, EU MDR) and product development processes
* Experience working with cross-functional teams in a matrixed organization
Skills & Competencies:
* Deep knowledge of standards management and regulatory compliance
* Strong analytical and problem-solving skills
* Excellent communication and stakeholder management abilities
* Ability to lead meetings and drive cross-functional alignment
* Detail-oriented with strong organizational skills
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Required Skill Profession

Operations Specialties Managers