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Escalation and Standards Quality Lead

Description

Escalation and Standards Quality Lead
Under NPD Quality & Compliance Manager and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Compliance with Standards

• Responsible for implementing Quality & Compliance processes and Standards for products (including External and Internal J&J standards and processes) and leads related activities
• Participate in quarterly Global Standards Council and review reports, and lead R&D Council assessments for inclusion of tracking specific standards in the Standards and Regulations Management Meetings
• Lead and manage Standards and Regulations Management Meetings
• Facilitate and follow up on Gap assessments of External and J&J standards Notifies SMEs about new standards or updated revisions and initiates related activities
• Follow up with SMEs and drive standards compliance to completion
• Maintain Standards and Regulations Management SOP and list of applicable standards
• Performs as SME and provides guidance and support in matters related to standards during Quality Audits, CAPA investigations, and technical documentation updates
• Provides quality inputs to the NPD Quality & Compliance (Quality Plan) and Project teams (CTQ)
• Develop and explore methodologies and deploy reliability and quality measures in NPD

Escalation of Quality and Regulatory Compliance Issues

• Monitoring signals of a potential escalation for Product Safety, Quality, or Regulatory & Compliance issues (complaints, defects, early triggers etc.)
• Report potential or confirmed Product Quality Issues or Regulatory & Compliance events to the appropriate Quality and Compliance organization for evaluation for escalation, notify Escalation Team
• Leads failure investigations and escalation of product issues: collect data (failure analysis, product affected, complaints analysis, risk assessment, etc.) and coordinates investigation associated with the product issue under review in order to define the problem to be evaluated
• Collaborate with cross-functional internal and external teams: Quality, RA, R&D, Clinical, MSO, etc.

Requirements

Experience
• Experience as a Quality Engineer (preferably experience in an active medical devices company)
• Advantage: Experience in Six Sigma methodology
• Advantage: Experience in statistical methods implementation during product design
• Experience in regulations

Education/Training
• BA degree – required
• Preferable - BSc in engineering science / ME / BA in Quality or Statistics or equivalent field

Location: יקנעם

Comments

Biosense Webster is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.