Quality & Regulatory Leader for Medical Devices Site

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

Job summary

Resonetics is seeking a Quality Manager at a site in the United States to lead quality and regulatory activities for contract manufacturing of medical device components. You will interface with customer supplier quality and internal teams, manage the site Quality department budget, and oversee hiring and policy development in line with Resonetics directives.

The role emphasizes Lean Six Sigma, process validation, metrology development, and commitment to ISO compliance while driving continual

Qualifications

• 8+ years in a Quality Engineering role for medical devices or equivalent.
• Demonstrated technical writing and communication skills.
• Working knowledge of statistical software and/or Minitab.
• Bachelor’s degree or equivalent experience; supervisory experience.
• Preferred: CMQOE, CQE and/or Six Sigma Green/Black Belt.

Responsibilities

• Liaising with customer quality personnel to resolve issues and customer complaints.
• Monitoring and disseminating customer quality report cards.
• Generating process deviations, validation protocols and reports.
• Generating Customer Change Notices.
• Assisting with troubleshooting of production and PDP processes.
• Leading development of metrology equipment.
• Developing and maintaining quality/control plans.
• Developing PFMECA's and Gage R&R studies.
• Conducting Gage R&R studies and audits.
• Developing Quality Procedures and ensure training of personnel.
• Approving nonconformance disposition and managing CAPAs.

Skills

Quality Engineering

Leadership/Supervision

Technical writing

Minitab

Statistical software

Education

Bachelor’s degree or equivalent experience

BS degree in science/engineering preferred

Tools

Minitab

Job description

Resonetics is seeking a Quality Manager at a site in the United States to lead quality and regulatory activities for contract manufacturing of medical device components. You will interface with customer supplier quality and internal teams, manage the site Quality department budget, and oversee hiring and policy development in line with Resonetics directives.

The role emphasizes Lean Six Sigma, process validation, metrology development, and commitment to ISO compliance while driving continual