Overview

The Quality Manager provides customer-and factory-facing quality support for contract manufacturing of medical device components at a specific Resonetics site. The position includes managing the interface between Resonetics and customers’ supplier quality organization, assisting with transition and sustaining of manufacturing processes, and support for supplier quality management.

The Quality Manager also acts as the lead person for a manufacturing site for all Quality and Regulatory matters and supervises other quality personnel on site. The Quality Manager oversees the site Quality department budget, Quality personnel hiring for the site, and establishes site-level policies to comply with Resonetics-wide directives. The Quality Manager is responsible for implementing new and revised corporate quality systems documents.

The Quality Manager is the Resonetics site Management Representative and leads facilitation of external audits. The Quality Manager position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, and ISO compliance.

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
  
  

• 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