NPD Quality & Compliance Lead

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 NPD Quality & Compliance Lead to be in Yokneam.

Key Responsibilities:
Lead quality and compliance efforts during product development phases.
Implement and maintain quality and compliance processes and standards for new product introductions, including adherence to internal J&J protocols.
Oversee risk management activities throughout the Product Development Process (PDP), including planning, FMEAs, reporting, post-market surveillance (PMS), and issue investigations.
Serve as a member of the Safety Management Team (SMT).
Participate in the Defect Classification Board; review defects and clinical readiness results, escalating potential quality and safety concerns.
Provide quality input, participate in, and approve design reviews and design changes.
Define quality plans and metrics for R&D projects; provide regular updates and status reports.
Initiate and lead company issue escalation processes and failure investigations.
Lead quality and compliance activities related to the development of product calibration tools, jigs, and R&D tools.
Analyze and approve off-the-shelf tools.
Manage the Design History File (DHF) and conduct DHF audit reviews in accordance with design control requirements.
Ensure product declarations of compatibility and compliance.
Support global activities including Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), and Clinical Readiness Reviews (CRRs).
Participate in product release processes, including Engineering Change Order (ECO) review and approval.
Communicate business-related issues or opportunities to the appropriate management level.

Quality & Company Compliance

Act as the Quality & Compliance representative, ensuring adherence to relevant standards.
Lead investigations and corrective/preventive actions (CAPA) in response to product issues.
Conduct internal audits and support external audit preparations.
Lead design-related problem investigations and quality improvement initiatives.
Present design project status during Quality System Management Reviews (QSMR).
Qualifications:

Education & Training

Required: Bachelor’s degree.
Preferred: BSc in Engineering, Mechanical Engineering, Quality, Statistics, or a related field.

Experience

Proven experience as a Quality Engineer and/or Quality Manager, ideally within an active medical device company.
Preferred experience with Six Sigma methodologies (Black Belt certification is an advantage).
Experience applying statistical methods during product design.
Demonstrated success in leading projects or process improvements.

Required Knowledge

ISO 13485
EN ISO 14971
QSR 21 CFR 820
EU MDR 2017/745 & Directive EEC/93/42
Familiarity with international standards related to QMS and medical products (e.g., IEC 60601, IEC 62304, MDSAP).
Advantageous: Knowledge of electronic records, privacy regulations, HIPAA, and FDA 21 CFR Part 11.

Skills & Competencies

Strong interpersonal and communication skills.
High integrity and self-confidence.
Self-motivated and capable of working independently or within teams.
Strategic thinker with a results-driven mindset.
Detail-oriented with a broad perspective.

Certifications (Preferred)

Certified Auditor (especially with experience in active medical devices).
CQE (Certified Quality Engineer), CSQE (Certified Software Quality Engineer), CRE (Certified Reliability Engineer).

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