Quality Manager

Overview:

This role is responsible for supporting quality initiatives to ensure that Breathe Technologies’ design, development and manufacturing processes consistently comply with regulatory requirements, customer/patient expectations and best practice industry standards. This individual will be expected to apply knowledge of design control principles and quality engineering processes to develop, manufacture and sustain medical devices in accordance FDA Quality System Regulations, ISO 13485 Quality Management System requirements and ISO 14971 Risk Management for Medical Devices expectations.

Essential Responsibilities:

  • Collaborate with product design/development engineering, regulatory, clinical and manufacturing operations to ensure appropriate quality requirements are defined and satisfy target patient population expectations

  • Support development, implementation and maintenance of Design Verification & Validation (V&V) methodologies and best practices to impact product launch timeliness, improve implementation of design enhancements and reduce number of design iterations

  • Support complaint management and post market surveillance activities

  • Develop, implement and maintain complaint trending and adverse event/significant event escalation processes

  • Assist in the implementation of Complaint Review Board Processes utilizing statistical process control techniques

  • Gather, evaluate, assess and trend product performance data to support Management Review process and identify opportunities for improvement

  • Analyze quality performance indicator data and investigate adverse trends to identify variables that may negatively affect product and processes

  • Lead internal audit process and manage audit schedule

  • Support regulatory agency inspections and Notified Body Audits, including management of the Inspection/Audit War Room

  • Review Engineering Change Orders to ensure compliance to regulatory expectations

  • Manage document control activities and implement scheduled SOP review process

  • Identify, implement and maintain process for long-term secure storage for legacy documentation (i.e., Iron Mountain)

  • Serve as Subject Matter Expert for regulatory inspections related to Quality Systems (Internal Audits, Document Control and Change Control)

Education/Experience:

 REQUIRED EDUCATION:

  • BS Degree in Mechanical, Electrical or Biomedical Engineering

REQUIRED QUALIFICATIONS:

  • 8+ years quality engineering experience

  • 5+ years Class II or Class III medical device experience

  • 5+ years supervisory or management experience

  • Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices

  • Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules

  • Able to constructively collaborate with cross-functional teams

DESIRED QUALIFICATIONS:

  • Experience with injection molded components, including; Mold Qualification, First Article Inspection Process Validation and Process Controls

  • Experience with electro-mechanical devices

  • ASQ Certification (Certified Quality Engineer, Certified Quality Manager)

  • Demonstrated ability to act as Subject Matter Expert related to Quality Systems

  • Experience supporting regulatory agency inspections and Notified Body Audits in an SME role

 

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