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Quality Manager – Lead QMS & Continuous Improvement

Woodway USA · Waukesha

🇬🇧 English
ISO 13485

Job description

About the role

We are looking for a dynamic Quality Manager to oversee quality systems across three manufacturing companies operating from two facilities in Waukesha, WI. The role will drive compliance with ISO standards, align quality initiatives with business goals, and ensure that customer expectations are consistently exceeded.

Key responsibilities

  • Develop, implement, and maintain a robust Quality Management System (QMS) in line with ISO 13485 and ISO 9001.
  • Lead internal and external quality audits, manage corrective actions, and track key performance indicators (KPIs).
  • Collaborate with engineering, supply chain, and production teams to embed quality assurance into new product development and manufacturing processes.
  • Monitor supplier performance, enforce supplier quality standards, and drive continuous improvement across the supply chain.
  • Analyze field quality data, incorporate customer feedback, and lead risk‑mitigation initiatives.
  • Manage the quality department’s human resources functions, including hiring, performance evaluations, and staff development.

Required profile

  • Proven experience leading quality systems in a multi‑site manufacturing environment.
  • Strong understanding of regulatory requirements and ability to translate them into actionable processes.
  • Excellent communication and leadership skills, with a track record of influencing cross‑functional teams.

Required skills

  • ISO 13485
  • ISO 9001
  • Quality Management System (QMS) implementation

What we offer

  • Opportunity to shape quality strategy across three companies.
  • Competitive benefits package.
  • Collaborative work environment focused on continuous improvement.

Questions fréquentes

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Published 3 months ago

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Woodway USA

Waukesha