Site Quality Assurance Manager

Skills Alliance; Connecticut; On-site; USD 110,000 - 160,000; Full time

Job summary

Skills Alliance is seeking a Site Quality Manager to oversee quality operations at a medical device contract manufacturing site. You will lead the team, manage budget and hiring while ensuring regulatory compliance and excellent cross-site collaboration with device customers.

This role focuses on driving CAPA, audits, and continuous improvement across the site. You will own process validations, PFMEAs, control plans and supplier scorecards, using Lean Six Sigma methods to cut waste and improve

Qualifications

• 8+ years of quality engineering experience in medical devices.
• Experience supervising a quality team.
• Strong knowledge of ISO 13485 and process validation.
• Proficiency with statistical tools (e.g., Minitab) and capability to communicate clearly.

Responsibilities

• Lead all Quality and Regulatory matters for the site, including team, budget and hiring.
• Act as main quality contact for customers' supplier quality teams and manage scorecards.
• Own process validations, deviations, PFMEAs, control plans and Customer Change Notices.
• Drive CAPA, approve nonconformance decisions and lead audits (internal and external).
• Specify metrology equipment, run Gage R&R studies and reduce reliance on inspection.

Skills

Quality engineering leadership

Team leadership

Regulatory compliance

Process improvement

Education

Bachelor's degree in engineering or science

Tools

Minitab

Statistical tools

Job description

Site Quality Manager, Medical Device Contract Manufacturing

Job Type: Full time - Permanent

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:

• Lead all Quality and Regulatory matters for the site, including the team, budget and hiring


• Act as the main quality contact for customers' supplier quality teams, resolving complaints and managing scorecards


• Own process validations, deviations, PFMEAs, control plans and Customer Change Notices


• Drive CAPA, approve nonconformance decisions and lead internal and external audits


• Specify metrology equipment, run Gage R&R studies and reduce reliance on inspection


• Use Lean Six Sigma to solve problems and improve processes

What you'll bring:

• 8+ years in Quality Engineering within medical devices


• Prior experience supervising a quality team


• Strong working knowledge of ISO 13485, process validation and statistical tools such as Minitab


• Clear technical writing and confident customer communication


• Bachelor's degree in engineering or science (Physics, Optics, Mechanical, Chemical or Plastics preferred)


• CQE, CMQ/OE or Six Sigma Green/Black Belt (preferred)

This is a chance to own quality at a site level in a growing, innovation-led business, working directly with major medical device customers.