Skills Alliance

Site Quality Manager, Medical Device Contract Manufacturing
Job Type: Full time - Permanent
Location: Bethel, CT (onsite) 📍
A global leader in precision micro manufacturing for the medical device industry is growing fast across its sites. They partner with many of the world's leading device companies, making the tiny, high-precision components that go into life-saving products. They're now looking for a Site Quality Manager to lead quality at one of their manufacturing sites.
What you'll do:
<ul>
<li>Lead all Quality and Regulatory matters for the site, including the team, budget and hiring</li>
<li>Act as the main quality contact for customers' supplier quality teams, resolving complaints and managing scorecards</li>
<li>Own process validations, deviations, PFMEAs, control plans and Customer Change Notices</li>
<li>Drive CAPA, approve nonconformance decisions and lead internal and external audits</li>
<li>Specify metrology equipment, run Gage R&amp;R studies and reduce reliance on inspection</li>
<li>Use Lean Six Sigma to solve problems and improve processes</li>
</ul>
What you'll bring:
<ul>
<li>8+ years in Quality Engineering within medical devices</li>
<li>Prior experience supervising a quality team</li>
<li>Strong working knowledge of ISO 13485, process validation and statistical tools such as Minitab</li>
<li>Clear technical writing and confident customer communication</li>
<li>Bachelor's degree in engineering or science (Physics, Optics, Mechanical, Chemical or Plastics preferred)</li>
<li>CQE, CMQ/OE or Six Sigma Green/Black Belt (preferred)</li>
</ul>
This is a chance to own quality at a site level in a growing, innovation-led business, working directly with major medical device customers.

Site Quality Assurance Manager

Site Quality Assurance Manager

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