Quality Assurance Manager

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry.

We are looking for a Quality Assurance Manager.

Responsibilities

• Performs and supports the work using quality risk management principles and their application to medical device manufacturing.
• 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 process development processes
• Leading development of metrology equipment
• Developing and maintaining quality/control plans
• Developing PFMECAs
• Specifying metrology equipment
• Conducting Gage R&R studies
• Resolving Corrective and Preventive Actions
• Developing Quality Procedures and ensure training of personnel
• Approving Nonconformance disposition
• Analyzing production and validation data
• Working on continual improvement and process assessment projects as assigned
• Supervising quality department for a site

Required Qualifications

• Minimum 8 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience
• Demonstrated technical writing and communication skills.
• Have proven experience leading the facilitation of external audits
• Working knowledge of 21 CFR Part 820 and/or ISO 13485 compliance
• Working knowledge of Statistical software and/or Minitab
• Bachelor’s degree or equivalent experience
• Prior supervisory experience