Job ID: 11816

Senior Quality & Regulatory Manager (m/f/d)

Stellenart.

Festanstellung

Ihre Aufgaben.

As the Senior Quality & Regulatory Manager (m/f/d) of the Material Characterization Business you will be leading cross-functional initiatives at international scale in support of our Strategy. Quality & Regulatory (Q&R) is a multi-disciplined team that provides objective insights and expertise in building robust Quality Systems based on business process excellence, structured problem solving, Environmental Health & Safety and regulatory compliance.

Responsibilities

  • Drive Customer satisfaction by serving as the primary liaison on quality for both internal and external suppliers, customers and stakeholders.
  • Support the organization with strategy deployment and KPI leadership management.
  • Own, measure and improve core QA processes (e.g., Internal Audit, CAPA, Non-conformity, complaint processes).
  • Ensure integrity in the documented Quality and Environmental Management system.
  • Support the principle elements of Lean leadership (e.g., Daily Management / Accountability, Discipline and Leader Standard Work).
  • Track and report on process quality trends, closely work with other stakeholders to track and report on product quality trends.
  • Employ quality techniques to aide multiple sites in management of problem solving.
  • Participate in all new product design and launch reviews to ensure product Quality, safety and environmental compliance.
  • Assures compliance with applicable internal and external regulations, policies and procedures related to product safety and EHS for the site.
  • Represent Business in relevant internal/external audits and interact with international/national, state, local and international agencies governing product regulations and laws.

Ihr Anforderungsprofil.

  • Many years of quality and regulatory experience working in an ISO 9001/14001 environment.
  • Bachelor’s engineering Degree or equivalent experience in a technical/scientific field.
  • Experience in Pharma, Medical Device and/or Battery Industry a plus.
  • Trained in Lean Sigma/Six Sigma processes.
  • Experience working in high-tech environment, and specifically capital equipment.
  • Experience to judge engineering solutions and their impact in product safety (e.g. electrical, mechanical, laser safety).
  • A demonstrated working knowledge of environmental compliance, e.g. RoHS, REACH, prop 65 EPA regulations.
  • A demonstrated working knowledge of the Product safety directive.
  • Good knowledge of electrical safety standards, preferable the IEC 61010-1, NFPA 79 standards.
  • Able to work independently, be a self-starter.
  • Experience working in high-tech environment, and specifically capital equipment.
  • Effective and persuasive communicator with the ability to effectively convey ideas to all levels of management.
  • Be hands-on and ready to roll up the sleeves to fill in where required in meeting the site or departmental objectives.
  • Ability to travel domestically approximately ≤25% of the time

Vorteile.

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Gehalt.

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