Director, Continuous Improvement/Quality

Barry-WehmillerFlagstaff, AZ
1d

About The Position

Where precision, innovation, and continuous improvement meet. Machine Solutions is hiring a Director who can amplify Lean excellence while strengthening the quality systems behind industry‑defining MedTech equipment. Join the team that’s revolutionizing medical device manufacturing. Machine Solutions is a global leader in advanced equipment and technologies used to manufacture life‑changing medical devices—from catheter and stent technologies to cutting‑edge automation systems. The company continues to innovate and expand, with brands unified under one powerful mission: to deliver solutions that advance lives through passion and purpose. With 20+ years of growth, a global footprint spanning North America and Europe, and a reputation for engineering excellence, Machine Solutions blends small‑company agility with industry‑defining innovation. Now, we’re looking for a hands-on, transformational leader to elevate our operational excellence and quality systems across the network. Why This Role Matters As Machine Solutions continues its growth across medical device manufacturing technologies—including balloon catheter forming, stent crimping, medical wire braiding, and advanced automation—operational excellence and robust quality systems are essential to delivering the repeatable, reliable performance our customers rely on. This role is a player/coach opportunity at the heart of our strategy. You’ll shape the future of our Lean culture, simplify and harmonize Quality Management Systems across global sites, and lead improvement initiatives that directly strengthen our customers’ experience and outcomes.

Requirements

  • Bachelor’s in Engineering, Manufacturing, or related field (Master’s/MBA preferred)
  • 10+ years in manufacturing leadership with strong CI and Quality emphasis
  • Experience with highly engineered, made-to-order equipment
  • Demonstrated player/coach leadership style that build followership
  • Multi-site CI and QMS implementation experience
  • ISO 9001 expertise; FDA familiarity a plus
  • ERP/data analytics fluency (Power BI, Infor, etc.)
  • Ability to travel up to 50%
  • Excellent influencing and communication skills across all levels

Nice To Haves

  • Master’s/MBA

Responsibilities

  • Lead kaizen events, VSM, waste elimination, and throughput acceleration initiatives.
  • Embed Lean thinking into daily operations while building capability through mentoring and structured training.
  • Standardize CI frameworks, visual management, and KPI structures across the global network.
  • Drive measurable improvements in margin, cost, quality, and delivery performance.
  • Influence design teams by championing Design for Excellence methods that enhance manufacturability, reliability, and cost efficiency.
  • Advancing ISO 9001–aligned QMS frameworks across multiple facilities.
  • Supporting FDA‑relevant processes for select Class II equipment.
  • Leading risk‑based quality planning through FMEA, Control Plans, and APQP.
  • Driving high-performing CAPA execution, internal and supplier audits, and quality performance dashboards.
  • Ensuring quality is built into design and manufacturing—from first article through scaled production.
  • Mentor site leaders and CI/Quality practitioners across multiple international facilities.
  • Dive directly into complex problems where dedicated CI resources don’t yet exist.
  • Build Lean and Quality capability that becomes self-sustaining.
  • Influence cross-functional teams—including Operations, Engineering, Supply Chain, and Service.
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