Senior Quality Manager – Medical Devices Manufacturing

Resonetics; Blaine (GA); On-site; USD 115,000 - 143,000; Full time

Job summary

Resonetics is seeking a Quality Manager at a U.S. site to provide customer- and factory-facing quality support for contract manufacturing of medical device components.

You will interface with customers’ supplier quality organizations, assist transitions, and support supplier quality management. You’ll lead the site Quality department, manage budget and hiring, establish site policies, and apply Lean Six Sigma, validations, and ISO compliance to drive continuous improvement while coordinating

Qualifications

• 8+ years in a Quality Engineering role for medical devices
• Strong technical writing and communication skills
• Experience with statistical software (Minitab) and data analysis
• Bachelor’s degree or equivalent experience
• Prior supervisory experience

Responsibilities

• Liaise with customer quality personnel to resolve issues and customer complaints
• Monitor and disseminate customer quality report cards
• Generate process deviations, validation protocols and reports
• Generate Customer Change Notices
• Assist with troubleshooting of production and PDP processes
• Lead development of metrology equipment
• Develop and maintain quality/control plans
• Develop PFMEA/CPMF
• Specify metrology equipment
• Conduct Gage R&R studies
• Resolve corrective and preventive actions
• Develop quality procedures and train personnel
• Approve nonconformance disposition
• Analyze production and validation data
• Support continual improvement projects and audits
• Supervise quality department for site
• Coordinate external/internal audits

Skills

Quality engineering

Statistical analysis

Technical writing

Supervisory experience

Education

Bachelor's degree or equivalent

Tools

Minitab

Statistical software

Job description

Resonetics is seeking a Quality Manager at a U.S. site to provide customer- and factory-facing quality support for contract manufacturing of medical device components.

You will interface with customers’ supplier quality organizations, assist transitions, and support supplier quality management. You’ll lead the site Quality department, manage budget and hiring, establish site policies, and apply Lean Six Sigma, validations, and ISO compliance to drive continuous improvement while coordinating