Senior Quality & Regulatory Manager – Med Device

JVT Advisors; Bethel (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

JVT Advisors is seeking a Full-time Quality Manager in Bethel, CT to lead the site quality and regulatory program for contract manufacturing of medical device components. You will supervise the site Quality department, manage budgets, and develop site-level policies aligned with company directives.

You will apply Lean Six Sigma, drive process validations and metrology development, and coordinate with customer supplier quality teams to ensure compliant, quality outcomes across manufacturing and

Qualifications

• 8+ years in quality engineering for medical devices or equivalent.
• Strong technical writing and communication skills.
• Proficiency with statistical software and Minitab.
• Bachelor's degree or equivalent experience.

Responsibilities

• Liaise with customer quality personnel to resolve issues and complaints.
• Monitor and disseminate customer quality scorecards.
• Generate deviation, validation protocols, and reports.
• Lead development of metrology equipment.
• Develop and maintain quality/control plans.
• Oversee site quality audits and CAPA processes.
• Facilitate external and internal audits.
• Drive continual improvement and process assessment.

Skills

Quality Engineering

Lean Six Sigma

Statistical software

Minitab

Technical writing

Communication skills

Education

Bachelor's degree

Job description

JVT Advisors is seeking a Full-time Quality Manager in Bethel, CT to lead the site quality and regulatory program for contract manufacturing of medical device components. You will supervise the site Quality department, manage budgets, and develop site-level policies aligned with company directives.

You will apply Lean Six Sigma, drive process validations and metrology development, and coordinate with customer supplier quality teams to ensure compliant, quality outcomes across manufacturing and