Quality Management Director
Job Description SummaryReporting to the VP Quality, the Quality Management Director will provide leadership for our Infusion Platform within the Medical Management Systems business unit with a scope that includes everywhere outside of US.
You will be responsible for the management of the Infusion platform quality assurance team (c.60 people). As the most senior Quality professional for the segment in the region, you will provide bold, strategic leadership in order to drive positive outcomes, change and transformation.
The role creates a strong link into the MMS Infusion platform business and significantly influences the strategy and assures alignment of tactics to achieve business objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; you will ensure product safety, product quality and compliance with all relevant global regulations and customer expectations.
You will also:
Be responsible for Quality Management across the international region, including (but not limited to) Quality Ops, Compliance, Design and QMS.
Provide BD executive management with assessments of evolving field issues. Develop strategies to correct and prevent these issues.
Work with leadership to assess and execute field actions per BD procedures.
Ensure effective and compliant quality operation for quality engineering, CAPA, non-conformance, customer complaint investigation, engineering change management, management review, and other relevant aspects of the quality system.
Develop plans to implement Corporate Quality Strategies
Active involvement in remediation of significant issues related to quality performance connected to manufacturing.
Oversee quality activities at the manufacturing plants producing Infusion pump products.
Continuously improve quality processes and quality system with the goal of improving regulatory compliance, product quality and customer satisfaction.
Establish quality capabilities at future manufacturing locations selected. Develop and execute a quality strategy for infusion pumps and associated software.
Serve as SME during government agency and Notified Body inspections Serve as Quality representative on Platform Leadership Team Champion continuous process / product improvement.
You will have 10+ years in senior, quality management roles within complex, global, Medical Device organisations of scale. You will have a strong track record working with international teams and experience working autonomously on all aspects of Quality Management.
You will also have:
Experience working with Medical Devices or Diagnostics, ideally durable devices.
Demonstrated expertise in working with Regulatory Agencies to address issues.
Initiative in innovative approaches to quality Management in a fast-paced changing business environment.
Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
Ability to think strategically and see the 'bigger picture'
Pro-active, with a desire to drive change and positive transformation
BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
This role will be based in Eysins, Switzerland
If this sounds like you, we would love to hear from you. Please hit Apply!
Primary Work LocationCHE Eysins - Business Park Terre-Bonne
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