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
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