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