Quality Manager JB-4417

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

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

· 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