Site Quality Leader - Medical Device Manufacturing

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

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