Senior Quality Leader - Medical Device Manufacturing

Resonetics; Bethel (CT); On-site; USD 115,000 - 143,000; Full time

Job summary

Resonetics in Bethel, CT seeks an experienced Quality Manager to lead the site Quality department, interfacing with customers and internal teams to ensure compliance with regulatory standards. You’ll oversee audits, CAPAs, process validations, and supplier quality initiatives, directing a team of quality professionals in a fast-paced manufacturing environment.

Responsibilities include developing quality plans, leading problem solving with Lean Six Sigma, and maintaining ISO compliance while

Qualifications

• Must have 8+ years in Quality Engineering for medical devices or equivalent engineering experience.
• Strong technical writing and communication skills.
• Experience with Statistical software (e.g., Minitab).

Responsibilities

• Lead site quality and regulatory activities for the manufacturing site.
• Interface with customer quality personnel and supplier quality organizations.
• Develop and maintain quality/control plans and CAPAs.
• Oversee internal and external audits and document control.

Skills

Technical writing

Communication

Statistical software

Education

Bachelor's degree

Tools

Minitab

Job description

Resonetics in Bethel, CT seeks an experienced Quality Manager to lead the site Quality department, interfacing with customers and internal teams to ensure compliance with regulatory standards. You’ll oversee audits, CAPAs, process validations, and supplier quality initiatives, directing a team of quality professionals in a fast-paced manufacturing environment.

Responsibilities include developing quality plans, leading problem solving with Lean Six Sigma, and maintaining ISO compliance while